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A binaural beat is an auditory impression regarded when two different pure-tone sine waves, both with frequencies less than 1500 Hz, with less than a 40 Hz difference between them, exist to an audience dichotically (one through each ear).
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Binaural defeated modern technology (BBT) was uncovered in the very early 1800s and also first described in the preferred literary works in the very early 1970s. In the last 4 decades, binaural beat audio programs have been proclaimed as tools for reducing anxiety, enhancing sleep, boosting focus, and even promoting modified states of consciousness.
Binaural beats are made use of along with isochronic tones, so it is recommended that you use earphones for ideal outcomes.
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In a state of complete leisure, the mind runs at a regularity varying between 7 and13 Hz (Alpha), while in a state of active thinking and also focus, the mind’s regularity rises to 13-40 Hz (Beta). Since an alpha state matches to a state of relaxation, we could think that stress, being a common cause of migraine headaches, manifests within the higher frequency arrays. With the usage of brain entrainment binaural beats, it is possible to entrain your brainwaves from a Beta regularity down to Alpha or also Delta (-4 Hz), so as to eliminate that uncomfortable throbbing experience.
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Forging Elite Fetuses
Ashley set to announce that she is growing a human.
My fellow Ktowners,
I’d like to tell you about my 2-year journey that will hopefully be bringing another option to you and yours within the Knoxville CrossFitting community by year’s end.
Thank you in advance for accepting my humble plea for support and sharing. Now, without further ado:
June 4, 2016: Following a local trail race, I sought out one of those poor souls who stretch sweaty runners in hopes of gaining a client. Dr. Patrick Zitt was that day’s ill-fated chiropractor. I shared with Dr. Z that I had tried chiropractic care for chronic migraines with no results and bad experiences. Code for: “ just stretch my legs, man, I ain’t buyin’. ” Jokes on me, because Dr. Z had a similar story — one of long time, debilitating migraines that he eventually got under control with a multitude of lifestyle changes. Desperate for relief, I made an appointment to see him the next week.
November 2016: Treatment was helping. My body felt great and my headaches were lessening with the help of chiropractic, physical + massage therapy, nutrition changes and a mindfulness practice; however, I was still having roughly 20 migraines a month . Yes, 20. Long story short, Dr. Z and I began to take my life apart to pinpoint when my migraines increased. We discovered two things:
1) Beginning a full time job.
2) Beginning hormonal birth control.
One of these two things could be changed. One could not. I began exploring options for coming off of hormonal contraceptives, which was terrifying (and I’ll stop there), because this isn’t a post about that process, but about where the process led me, which is a program and organization called Birthfit.
*Note, I could write a book about coming off of birth control, how terrifying it was, the discussions that occurred with my husband, the lack of information/education available, the crazy looks I got from friends. I’d love to talk about all of that if you find yourself in a similar situation.*
March 2017: Queued up for my morning drive was Girls Gone Wod Podcast Episode 194, an interview with Dr. Lindsey Mathews, Founder and CEO of Birthfit. Between the terrifying life choice above and this episode, I had been on a knowledge quest regarding all things women’s health including, but not limited to: how to avoid pregnancy without taking hormonal birth control (which I did successfully until my husband and I decided we wanted to stop preventing children from entering our lives), the effects of synthetic hormones on male and female bodies, healing a woman’s cycle, how many female athletes struggle to conceive and stay pregnant despite being healthy, the role of doulas and midwives, how to actively help a woman pursue the birth she wants, keeping female athletes moving during and after pregnancy, and the (often kind of messed up) way that women are treated like ‘little men’ in Western medicine.
Birthfit spoke to all of this.
“Sign me up!” I thought. “I want to be a part of how my Crossfit community at Ktown can come alongside our moms and keep them fit, healthy, and supported in pregnancy. What an incredible program!”
[Insert sad trombone here] because a quick web search revealed that there was no Birthfit in Knoxville or its surrounding areas. But I kept learning and the more I learned, the more I loved what Birthfit was doing for the Crossfitting community around the world.
And so the inner voice began. “Should I start Birthfit in Knoxville? No. That’s silly. I’m a full time pastor. I’m training for races. I like my social life. I have no time for that. I don’t know how to start a business. No.” Repeat daily.
Fall 2017: The outer voice replies, “forget it” to the inner voice. “I’m going to bring Birthfit to Knoxville,” I said out loud to myself (*except it didn’t say “forget”, but that is less offensive just in case this thing works and people begin searching the internet for “Birthfit Knoxville, Tennessee”*)
I began explaining my vision to people, but couldn’t hit a vein of equal passion to get the program going. Insert more sad trombones and wondering how the [heck] to start this thing. I kept saying it out loud and stayed after talking options within the Knoxville area to anyone who would listen. I did this because I kept sensing a need for something like Birthfit in Knoxville — for women like me, for the women and their partners in my gym having miscarriages, for mommas wanting to stay strong and engaged while they grew a human through the sheer wild and ferocious power within their own body. And, as they say, necessity is the mother of invention.
January 2018: I caught wind of a certified Birthfit coach named Megh Martinez who had moved to Knoxville and wanted to start a Birthfit Region. I sent her an email that said this,
“Long story short, I am a United Methodist clergy person serving a small South/East congregation called Asbury. I’ve always had interest in maternity, empowering women, building community and health/fitness. Over the last year, I discovered the Fertility Awareness Method and began engaging more natural practices regarding women’s health and my own body. That, I have found, is just the tip of the iceberg in this journey for me. I’ve recently considered becoming a certified doula this year and wrote down a scary goal for 2018 of starting BirthfitKnoxville as a Birthfit Region.
I have been honest about not knowing how the [heck] any of that is going to happen over the last month of saying my hopes out loud.
Maybe you’re a piece of the puzzle.”
Today: I sat down to write this blog post for CrossFit Ktown announcing that Megh Martinez and I are in the application process to begin BirthfitKnox. We hope to be accepted, up and running in January 2019. We are beginning events and programs with the help of Birthfit Nashville between now and then. It is my hope to be able to offer Birthfit onsite at Ktown (duh! y’all are my home gym and win my heart) as we move into 2019 and beyond.
Below is more about Birthfit, our upcoming workshop and other opportunities to get involved. To say the least, I need your help to get this vision off the ground. I’d be ever grateful for your support via attending what we’ve got going on, sharing by word of mouth and social media what we’re doing and referring people our way. I’m excited to see what the future of BirthfitKnox holds and hope it can become another great part of both the CrossFit community in Knoxville and at Ktown!
I’d love to talk more if any of this strikes a cord with you. It is still my belief that women and partners like you and like me need this in Knoxville.
Here’s the quick down and dirty on Birthfit for those still reading:
What is Birthfit? BIRTHFIT is … …a movement. It’s about expecting and postpartum moms taking charge of their bodies and their decisions, and supporting one another’s journeys—together and apart. … an approach to birth. We challenge the status quo and ask the questions no one else asks. We read, research, experiment & consolidate all the common sense, time-honored wisdom & recent studies we can find and present that information to you through various education models. Our pillars are fitness, nutrition, chiropractic & mindset. We unconditionally support YOU—the birth mom & birth partner—to make the best decision for you and Baby. … a state of readiness. Childbirth is perhaps the most physical, mental & spiritual experience of a woman’s life. We want you to be ready in body, mind & spirit for the experience of birth and the lifelong journey that follows. … your support team. We are a team of practitioners, educators, chiropractors, coaches, nutritionists, fellow mamas, men & women who are involved in our local communities and we are all rooting for YOU.
Why should I do Birthfit prenatal or postpartum? A mantra you’ll hear from Birthfit is, “just because you can doesn’t mean you should.” Birthfit prenatal and postpartum programming and coaching helps to prepare you for and rehab you from the birth experience. Think about an Olympic track and field team, which contains long distance runners, sprinters, jumpers, etc.. You don’t see your mile runners practicing how to do a long jump or your sprinters working on a high jump. Olympic track and field athletes get super sports specific the entire year leading up to the Olympic trails and even more dialed in between trials and the Olympics. Pregnancy is like that. You have 40 weeks to train for the hardest MetCon of your life (as a woman) and Birthfit is a way to get sports specific with training elements such as strengthening the posterior chain, building proper breathing and lifting patterns and making workouts mimic contractions to get you ready for labor, delivery and postpartum recovery.
How do I get involved? Attend the July 14 Workshop *see details below. I know the price is high for something you might just want to investigate. However, I can give you my word that it will be worth your time and money if any of this blog post has sparked some passion in you. Keep an eye out on the gym’s social media and bulletin boards for our first postpartum class beginning in Knoxville in August/September. Exact dates, times and location TBA. Reach out and p ick my brain! I’d love to share more so you can tell people in your life about Birthfit or begin utilizing it for yourself in your motherhood transition. I’ve been following Birthfit’s 40 week prenatal programming and would be happy to explain the ins and outs of what I’m learning so far. My email is . Megh Martinez is also excited to share the vision with anyone interested in becoming a part of BirthfitKnox. Her email is Are you a practitioner or coach ? BirthfitKnox will be a cooperative hub of chiropractors, coaches, yoga instructors, doctors, nurses, physical therapist, massage therapist, and more to help connect Birthfit mommas and partners to supportive practitioners in our area. We want to build a team of people in Knoxville who are passionate providing services to women pre-conception, prenatal and postpartum that holistically support them in their motherhood transition.
BirthFit Nashville is coming to Knoxville!
Who should attend the BirthFit Workshop? Coaches, professionals, and practitioners who work with women in the motherhood transition and would like better tools to serve their clients. Pregnant and Postpartum Women Partners and loved ones who wish to support the women in their lives through the motherhood journey. Anybody interested in learning more about the BirthFit Movement.
Come join us at South Landing CrossFit this summer to learn more about the four pillars of BirthFit and what the movement is all about. Brittany Anderson of BirthFit Nashville will be leading us in lectures and practical application through movement. This is a great opportunity to learn all about Birthfit and the vision for getting it started in Knoxville.
Spots are limited, so sign up soon! Hope to see you there!
Sign up at birthfitnashville.com By crossfitktown | 2018-06-29T15:23:50+00:00 June 29th, 2018 | CrossFit Ktown Knoxville
Press Release: Novartis presents new data demonstrating long-term efficacy, safety and tolerability of Aimovig(R) (erenumab) in patients with chronic and episodic migraine
Press Release: Novartis presents new data demonstrating long-term efficacy, safety and tolerability of Aimovig(R) (erenumab) in patients with chronic and episodic migraine 28.06.2018 – 22:30 | Quelle: Dow Jones Newswire Web | Lesedauer etwa 8 min. | Text vorlesen Stop Pause Fortsetzen facebook google+ twitter *DJ Novartis presents new data demonstrating long-term efficacy, safety and tolerability of Aimovig(R) (erenumab) in patients with chronic and episodic migraine(MORE TO FOLLOW) Dow Jones NewswiresJune 28, 2018 16:30 ET ( 20:30 GMT)Novartis International AG / Novartis presents new data demonstratinglong-term efficacy, safety and tolerability of Aimovig(R) (erenumab) inpatients with chronic and episodic migraine . Processed and transmittedby Nasdaq Corporate Solutions. The issuer is solely responsible for thecontent of this announcement. Results from a one-year study of efficacy and safety of Aimovig inchronic migraine and data from a three-year analysis assessing safety andtolerability of Aimovig in episodic migraine will be presented at AHS Aimovig showed robust efficacy in patients with chronic migraine, withsubstantial reductions in monthly migraine days sustained throughout thestudy Safety data in both studies were consistent with the placebo-like safetyprofile seen for Aimovig across the clinical trial program of 3,000patients Aimovig is the first and only FDA-approved treatment designedspecifically to prevent migraine; EMA approval is expected in the comingmonthsThe digital press release with multimedia content can be accessed here:https://novartis.gcs-web.com/Novartis-presents-new-data-demonstrating-long-term-efficacy-safety-and-tolerability-o-Aimovig-erenumab-in-patients-with-chronic-and-episodic-migraine%20Basel, June 28, 2018 – Novartis today announced the results of twoopen-label extension studies (OLE) of Aimovig(R) (erenumab) in patientswith chronic and episodic migraine, which will be presented at the60(th) Annual Scientific Meeting of the American Headache Society in SanFrancisco,. The data reinforce the established safety and efficacyprofile of Aimovig in long-term use for patients with chronic migraine.In addition, data will be presented from the longest running study of aCGRP therapy, demonstrating the long-term safety and tolerability ofAimovig in episodic migraine. Aimovig is the first and only FDA-approvedtreatment specifically developed to prevent migraine by blocking thecalcitonin gene-related peptide receptor (CGRP-R), which is believed toplay a critical role in migraine.In the study in chronic migraine patients (15 or more migraine days permonth), the primary and secondary endpoints were long-term safety andefficacy, respectively. The safety results after one year wereconsistent with the established safety profile of Aimovig in previousstudies. The most frequent adverse events (AEs) were viral upperrespiratory tract infection, upper respiratory tract infection,sinusitis, arthralgia, and migraine.The efficacy data showed sustained benefits up to one year. Compared toa baseline of 18.1 average monthly migraine days, patients takingAimovig 140mg and 70mg (based on last dose received) respectivelyachieved a: Substantial reduction of average monthly migraine days – 10.5 and 8.5days 50% or more reduction in monthly migraine days – 67% and 53% 75% or more reduction in monthly migraine days – 42% and 27% Migraine-free status (100% reduction) – 13% and 6%”These data showing sustained efficacy and consistent safety andtolerability of Aimovig over an extended period of time are importantfor migraine patients and their clinicians to know,” said Stewart J.Tepper, M.D., professor of neurology at the Geisel School of Medicine atDartmouth Medical School. “Collectively these data reinforce the safetyand tolerability of Aimovig, and having a treatment specificallydesigned for migraine has the potential to truly improve the lives ofthose living with this neurological disease.”The results from a three-year interim data analysis of the five-year OLEstudy assessing safety in episodic migraine (four or more migraine daysper month) showed Aimovig had a safety profile consistent with thespectrum and rate of AEs seen in shorter-term placebo-controlledstudies. The most frequent AEs were viral upper respiratory tractinfection, upper respiratory tract infection, sinusitis, influenza, andback pain and there were no new safety signals.”Following FDA approval, with European approval anticipated in thecoming months, we are very pleased to report positive long-term safetyand efficacy results for Aimovig,” said Danny Bar-Zohar, Global Head ofNeuroscience Development at Novartis Pharmaceuticals. “For patients whohave suffered from migraine for years, these new data further confirmthat Aimovig may offer long-term sustained and safe relief from migraineand the heavy burden it imposes.”Aimovig was approved by the FDA on May 17, 2018. The Committee forMedicinal Products for Human Use (CHMP) of the European Medicines Agency(EMA) delivered a positive opinion for Aimovig for the prevention ofmigraine in adults on May 31, 2018. The European Commission will reviewthe CHMP opinion before delivering its final decision.Novartis and Amgen are co-commercializing Aimovig in the U.S, Amgen hasexclusive commercialization rights to the drug in Japan and Novartis hasexclusive rights to commercialize in the rest of the world.About the Open-Label Extension Study in Chronic MigraineAfter the 12-week, Phase II, double-blind placebo-controlled parentstudy, eligible patients could enroll in the OLE. 451 people completedthe study receiving either Aimovig 70 mg, 140 mg or changing from 70 mgto 140 mg during the course of the study. Of the 609 patients whoenrolled in the study, 199 increased their dose from 70 mg to 140 mg byweek 28.The primary outcome measure of the study was long-term safety. Thesecondary outcome measure was efficacy, as determined by four measures:change from baseline to week 52 in monthly migraine days (MMD), monthlyacute migraine-specific medication days, monthly cumulative hours ofheadache, and proportion of patients achieving at least a 50% reductionin MMD.The most frequent adverse events (greater than 2.0 per100-subject-years) were viral upper respiratory tract infection, upperrespiratory tract infection, sinusitis, arthralgia, and migraine. In thedouble-blind treatment phase, no differences were observed in the safetyevents between Aimovig and placebo.About the Open-Label Extension Study in Episodic MigraineFollowing a Phase II 12-week double-blind, placebo-controlled study ofAimovig in adults with episodic migraine, patients could enroll in theOLE, initially receiving 70 mg Aimovig monthly. A protocol amendmentincreased the dosage to 140 mg monthly to assess long-term safety of thehigher dose. Safety and tolerability were assessed by monitoring AEs,electrocardiograms, laboratory assessments, and vital signs. Of the 383patients who enrolled in the open-label extension, 235 patients (61.3percent) remained in the OLE study at the data cutoff point for thisinterim analysis, all having received Aimovig for at least three years.The study is continuing for up to five years of treatment.Data at approximately four and five years of treatment will be reportedin the future.Aimovig is the only FDA-approved treatment specifically developed toprevent migraine by blocking the calcitonin gene related peptidereceptor (CGRP-R), which plays an important role in migraine. Aimovighas been studied in several large, global, randomized, double-blind,placebo-controlled studies to assess its safety and efficacy in migraineprevention. More than 3,000 patients have participated in our overall/clinical trial program across the four placebo-controlled Phase II andPhase III clinical studies, their open-label extensions and furtherstudies such as LIBERTY, a dedicated study in a difficult-to-treattreatment failure population.Migraine is a distinct neurological disease. It involves recurrentattacks of moderate to severe head pain that is typically pulsating,often unilateral and associated with nausea, vomiting and sensitivity tolight, sound and odors. Migraine is associated with personal pain,disability and reduced quality of life, and financial cost tosociety. It has a profound and limiting impact on an individual’sabilities to carry out everyday tasks and was reported by the WorldHealth Organization to be one of the top 10 causes of years lived withdisability for men and women. It remains under-recognized andunder-treated,. Existing preventive therapies have been repurposedfrom other indications and are often associated with poor tolerabilityand lack of efficacy, with high discontinuation rates among patients.About Novartis and Amgen Neuroscience CollaborationIn August 2015, Novartis entered into a global collaboration with Amgento develop and commercialize pioneering treatments in the field ofmigraine and Alzheimer’s disease. The collaboration focuses oninvestigational Amgen drugs in the migraine field, including Aimovig(approved by the FDA in May 2018 for the preventive treatment ofmigraine in adults) and AMG 301 (currently in Phase II development). InApril 2017, the collaboration was expanded to includeco-commercialization of Aimovig in the U.S. For the migraine program,Amgen retains exclusive commercialization rights in Japan, and Novartishas exclusive commercialization rights in Europe, Canada and rest ofworld. Also, the companies are collaborating in the development andcommercialization of a beta-secretase 1 (BACE) inhibitor program inAlzheimer’s disease. The oral therapy CNP520 (currently in Phase III forAlzheimer’s disease) is the lead molecule and further compounds fromboth companies’ pre-clinical BACE inhibitor programs may be consideredas follow-on molecules.Novartis has a strong ongoing commitment to neuroscience and to bringinginnovative treatments to patients suffering from neurological conditionswhere there is a high unmet need. We are committed to supporting(MORE TO FOLLOW) Dow Jones NewswiresJune 28, 2018 16:30 ET ( 20:30 GMT)
The Best Ways To HEAL MIGRAINE normally? Discover the causes & Ayurvedic natural home remedy for treating migraine headache.
Just what is a migraine headache? Clinical depression, irritability, pounding pain are the major symptoms of migraine headache.
A migraine headache can be a very disturbing scenario for those experiencing it. It is really persistent a takes a long period of time to subside. Migraine headache may be the outcome from a selection of causes such as low blood sugar, allergic reaction, infection, too much consumption of medications, a weak constitution, low power, inappropriate rest and also remainder, excessive cigarette smoking and also alcohol consumption and sex-related extravagance.
Allow us have an appearance at some of the symptoms of a migraine listed here to get a better understanding of it:
1. Throbbing discomfort: A migraine can be identified by a throbbing discomfort particularly in the direction of one side of the head.
Blind spots: The signs and symptoms of a migraine can vary from individual to individual. Some individuals experience a little obscured vision or blind spots before the onset of a migraine headache.
3. Level of sensitivity to light: A migraine headache could make an individual experience a pain in bright lights. They do not even like loud audios.
Let us have a fast look over the sources of migraine headache:
1. Allergies: Certain allergic reactions can additionally the trigger the beginning of a migraine. Some people that are sensitive to either food or due to ecological elements are vulnerable to migraine headaches.
2. Posture: Did you understand that bad postures can cause a migraine headache? YES! Sitting in an unpleasant position that is not great for your back or beck can be a potential trigger for a migraine headache.
2. Rest conditions: People that have rest conditions are the targets for migraine headaches. It is necessary to obtain ample amount of rest if you wish to keep migraines at bay.
3. Low blood sugar levels: Hypoglycemia is a significant variable that causes migraine headaches. Individuals who experience from low blood sugar level must get themselves examined up completely in order to maintain migraines away.
4. Hormonal discrepancies: This is yet another element or trigger for migraines. Hormonal fluctuations can induce poor migraines that remain on for an extended period of time.
Ways to cure migraine headache normally? Right here are some all-natural migraine headache therapies. Design trend provides time examined, ayurvedic residence remedies for your health.
Taking small dosages of grape juice several times a day offers wonderful remedy for migraine frustration.
Crusts of lemon pounded in a fine paste in a mortar must be used as a plaster on the forehead for migraine therapy.
200ml of spinach juice, combined with 300ml of carrot juice to prepare 500ml of the mixed juices assists in reducing the pain. This is a fantastic migraine treatment to obtain immediate alleviation from your migraine.
100ml of each of beet as well as cucumber juices, mixed with 300ml of carrot juices is beneficial for migraine treatment. Attempt out this remedy if you are looking for a fast relief.
Still wondering just how to cure migraine headache normally from residence? When you have this problem attempt our recommended ayurvedic treatments and see the distinction yourself, following time. Do share your experiences of these all-natural migraine treatments.
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Do Away With Headache Naturally – https://www.youtube.com/watch?v=KZKIReZ5AjA
Home Remedies For Insomnia & Sleep Disorders – https://www.youtube.com/watch?v=Sxwhdunpl0s
Natural Home Remedy For Hypoglycemia( Low Blood Sugar) – https://www.youtube.com/watch?v=o3SyYka2x3g
Novartis International AG: Novartis presents new data demonstrating long-term efficacy, safety and tolerability of Aimovig (erenumab) in patients with chronic and episodic migraine
Novartis International AG: Novartis presents new data demonstrating long-term efficacy, safety and tolerability of Aimovig (erenumab) in patients with chronic and episodic migraine
Novartis International AG / Novartis presents new data demonstrating long-term efficacy, safety and tolerability of Aimovig (erenumab) in patients with chronic and episodic migraine . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement. Results from a one-year study of efficacy and safety of Aimovig in chronic migraine and data from a three-year analysis assessing safety and tolerability of Aimovig in episodic migraine will be presented at AHS Aimovig showed robust efficacy in patients with chronic migraine, with substantial reductions in monthly migraine days sustained throughout the study Safety data in both studies were consistent with the placebo-like safety profile seen for Aimovig across the clinical trial program of 3,000 patients Aimovig is the first and only FDA-approved treatment designed specifically to prevent migraine; EMA approval is expected in the coming months The digital press release with multimedia content can be accessed here: (https://novartis.gcs-web.com/Novartis-presents-new-data-demonstrating-long-term-efficacy-safety-and-tolerability-o-Aimovig-erenumab-in-patients-with-chronic-and-episodic-migraine%20)
Basel, June 28, 2018 – Novartis today announced the results of two open-label extension studies (OLE) of Aimovig (erenumab) in patients with chronic and episodic migraine, which will be presented at the 60 th Annual Scientific Meeting of the American Headache Society in San Francisco,. The data reinforce the established safety and efficacy profile of Aimovig in long-term use for patients with chronic migraine. In addition, data will be presented from the longest running study of a CGRP therapy, demonstrating the long-term safety and tolerability of Aimovig in episodic migraine. Aimovig is the first and only FDA-approved treatment specifically developed to prevent migraine by blocking the calcitonin gene-related peptide receptor (CGRP-R), which is believed to play a critical role in migraine.
In the study in chronic migraine patients (15 or more migraine days per month), the primary and secondary endpoints were long-term safety and efficacy, respectively. The safety results after one year were consistent with the established safety profile of Aimovig in previous studies. The most frequent adverse events (AEs) were viral upper respiratory tract infection, upper respiratory tract infection, sinusitis, arthralgia, and migraine.
The efficacy data showed sustained benefits up to one year. Compared to a baseline of 18.1 average monthly migraine days, patients taking Aimovig 140mg and 70mg (based on last dose received) respectively achieved a: Substantial reduction of average monthly migraine days – 10.5 and 8.5 days 50% or more reduction in monthly migraine days – 67% and 53% 75% or more reduction in monthly migraine days – 42% and 27% Migraine-free status (100% reduction) – 13% and 6%
“These data showing sustained efficacy and consistent safety and tolerability of Aimovig over an extended period of time are important for migraine patients and their clinicians to know,” said Stewart J. Tepper, M.D., professor of neurology at the Geisel School of Medicine at Dartmouth Medical School. “Collectively these data reinforce the safety and tolerability of Aimovig, and having a treatment specifically designed for migraine has the potential to truly improve the lives of those living with this neurological disease.”
The results from a three-year interim data analysis of the five-year OLE study assessing safety in episodic migraine (four or more migraine days per month) showed Aimovig had a safety profile consistent with the spectrum and rate of AEs seen in shorter-term placebo-controlled studies. The most frequent AEs were viral upper respiratory tract infection, upper respiratory tract infection, sinusitis, influenza, and back pain and there were no new safety signals.
“Following FDA approval, with European approval anticipated in the coming months, we are very pleased to report positive long-term safety and efficacy results for Aimovig,” said Danny Bar-Zohar, Global Head of Neuroscience Development at Novartis Pharmaceuticals. “For patients who have suffered from migraine for years, these new data further confirm that Aimovig may offer long-term sustained and safe relief from migraine and the heavy burden it imposes.”
Aimovig was approved by the FDA on May 17, 2018. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) delivered a positive opinion for Aimovig for the prevention of migraine in adults on May 31, 2018. The European Commission will review the CHMP opinion before delivering its final decision.
Novartis and Amgen are co-commercializing Aimovig in the U.S, Amgen has exclusive commercialization rights to the drug in Japan and Novartis has exclusive rights to commercialize in the rest of the world.
About the Open-Label Extension Study in Chronic Migraine After the 12-week, Phase II, double-blind placebo-controlled parent study, eligible patients could enroll in the OLE. 451 people completed the study receiving either Aimovig 70 mg, 140 mg or changing from 70 mg to 140 mg during the course of the study. Of the 609 patients who enrolled in the study, 199 increased their dose from 70 mg to 140 mg by week 28.
The primary outcome measure of the study was long-term safety. The secondary outcome measure was efficacy, as determined by four measures: change from baseline to week 52 in monthly migraine days (MMD), monthly acute migraine-specific medication days, monthly cumulative hours of headache, and proportion of patients achieving at least a 50% reduction in MMD.
The most frequent adverse events (greater than 2.0 per 100-subject-years) were viral upper respiratory tract infection, upper respiratory tract infection, sinusitis, arthralgia, and migraine. In the double-blind treatment phase, no differences were observed in the safety events between Aimovig and placebo.
About the Open-Label Extension Study in Episodic Migraine Following a Phase II 12-week double-blind, placebo-controlled study of Aimovig in adults with episodic migraine, patients could enroll in the OLE, initially receiving 70 mg Aimovig monthly. A protocol amendment increased the dosage to 140 mg monthly to assess long-term safety of the higher dose. Safety and tolerability were assessed by monitoring AEs, electrocardiograms, laboratory assessments, and vital signs. Of the 383 patients who enrolled in the open-label extension, 235 patients (61.3 percent) remained in the OLE study at the data cutoff point for this interim analysis, all having received Aimovig for at least three years. The study is continuing for up to five years of treatment.
Data at approximately four and five years of treatment will be reported in the future.
About Aimovig (erenumab) Aimovig is the only FDA-approved treatment specifically developed to prevent migraine by blocking the calcitonin gene related peptide receptor (CGRP-R), which plays an important role in migraine. Aimovig has been studied in several large, global, randomized, double-blind, placebo-controlled studies to assess its safety and efficacy in migraine prevention. More than 3,000 patients have participated in our overall/ clinical trial program across the four placebo-controlled Phase II and Phase III clinical studies, their open-label extensions and further studies such as LIBERTY, a dedicated study in a difficult-to-treat treatment failure population.
About Migraine Migraine is a distinct neurological disease. It involves recurrent attacks of moderate to severe head pain that is typically pulsating, often unilateral and associated with nausea, vomiting and sensitivity to light, sound and odors. Migraine is associated with personal pain, disability and reduced quality of life, and financial cost to society. It has a profound and limiting impact on an individual’s abilities to carry out everyday tasks and was reported by the World Health Organization to be one of the top 10 causes of years lived with disability for men and women. It remains under-recognized and under-treated,. Existing preventive therapies have been repurposed from other indications and are often associated with poor tolerability and lack of efficacy, with high discontinuation rates among patients. About Novartis and Amgen Neuroscience Collaboration In August 2015, Novartis entered into a global collaboration with Amgen to develop and commercialize pioneering treatments in the field of migraine and Alzheimer’s disease. The collaboration focuses on investigational Amgen drugs in the migraine field, including Aimovig (approved by the FDA in May 2018 for the preventive treatment of migraine in adults) and AMG 301 (currently in Phase II development). In April 2017, the collaboration was expanded to include co-commercialization of Aimovig in the U.S. For the migraine program, Amgen retains exclusive commercialization rights in Japan, and Novartis has exclusive commercialization rights in Europe, Canada and rest of world. Also, the companies are collaborating in the development and commercialization of a beta-secretase 1 (BACE) inhibitor program in Alzheimer’s disease. The oral therapy CNP520 (currently in Phase III for Alzheimer’s disease) is the lead molecule and further compounds from both companies’ pre-clinical BACE inhibitor programs may be considered as follow-on molecules.
Novartis in Neuroscience Novartis has a strong ongoing commitment to neuroscience and to bringing innovative treatments to patients suffering from neurological conditions where there is a high unmet need. We are committed to supporting patients and physicians in multiple disease areas, including Multiple Sclerosis (MS), Alzheimer’s disease, Parkinson’s disease, Epilepsy and Attention Deficit Hyperactivity Disorder, and have a promising pipeline in MS, Alzheimer’s disease, migraine and specialty neurology (e.g., neuropathic pain).
Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for Aimovig or the other investigational or approved products described in this press release, or regarding potential future revenues from such products or the collaboration with Amgen. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Aimovig or the other investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that the collaboration with Amgen will achieve any or all of its intended goals and objectives, or be commercially successful. Nor can there be any guarantee that Aimovig or the other investigational or approved products described in this press release will be commercially successful in the future. In particular, our expectations regarding such products, and the collaboration with Amgen, could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 124,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com (http://www.novartis.com).
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References  Tepper S, et al. Assessment of the Long-Term Safety and Efficacy of Erenumab During Open-Label Treatment of Subjects With Chronic Migraine. Data presented at 60th Annual Scientific Meeting of the American Headache Society, San Francisco, June 2018  Ashina M, et al. Long-term Safety and Tolerability of Erenumab: Three-plus Year Results from an Ongoing Open-Label Extension Study in Episodic Migraine. Data presented at 60th Annual Scientific Meeting of the American Headache Society, San Francisco, 30 June 2018  Migraine Research Foundation. Migraine Fact Sheet. 2015. http://www.migraineresearchfoundation.org/fact-sheet.html (http://www.migraineresearchfoundation.org/fact-sheet.html). Accessed May 2018  National Institute for Neurological Disorders and Stroke. https://www.ninds.nih.gov/Disorders/All-Disorders/Migraine-Information-Page (https://www.ninds.nih.gov/Disorders/All-Disorders/Migraine-Information-Page) (link is external). Accessed March 2018  World Health Organization. Headache disorders. http://www.who.int/mediacentre/factsheets/fs277/en/ (http://www.who.int/mediacentre/factsheets/fs277/en/) (link is external). Accessed May 2018  Global Health Estimates 2015: Disease burden by Cause, Age, Sex, by Country and by Region, 2000-2015. Geneva, World Health Organization; 2016.  Diamond S et al. Patterns of Diagnosis and Acute and Preventive Treatment for Migraine in the United States: Results from the American Migraine Prevalence and Prevention Study. Headache. 2007;47(3):355-63.  Blumenfeld AM et al. Patterns of use and reasons for discontinuation of prophylactic medications for episodic migraine and chronic migraine: results from the second international burden of migraine study (IBMS-II). Headache. 2013 Apr;53(4):644-55. # # #
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