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Biohaven To Present 16 Abstracts At 2019 American Headache Society (AHS) Annual Scientific Meeting Highlighting New Data With Rimegepant, Oral CGRP Receptor Antagonist – NASDAQ.com

-Rimegepant leads the meeting with the most presentations for an oral small molecule CGRP receptor antagonist, including 14 late breakers -Oral Presentation of rimegepant Zydis® Orally Dissolving Tablet (ODT) Phase 3 results for the acute treatment of migraine -Phase 3 analyses examining efficacy of rimegepant regardless of migraine attack frequency and in patients taking concurrent preventive medications -Interim safety analysis from long-term, open-label safety study of rimegepant -First clinical reports evaluating acute treatment benefit of oral rimegepant in patients already being treated with injectable CGRP-targeting monoclonal antibodies for preventive therapy
NEW HAVEN, Conn., June 24, ), today announced it will be presenting 16 abstracts, including new efficacy and safety analyses from the Phase 3 rimegepant studies along with other important clinical results, at the 2019 American Headache Society Annual Scientific Meeting in Philadelphia, July 11-14, 2019. Rimegepant is an oral, single dose, selective and potent small molecule calcitonin gene-related peptide (CGRP) receptor antagonist in development for the acute treatment of migraine. These 16 abstracts encompass the largest volume of presentations for an oral, small molecule CGRP receptor antagonist at this meeting.
“The extensive data set we are presenting at AHS showcases the potential of rimegepant, our lead oral CGRP product candidate, as a novel and differentiated acute treatment for migraine,” said Vlad Coric, M.D., Chief Executive Officer of Biohaven.
Oral presentation details:
Presentation Title: Efficacy, Safety, and Tolerability of Rimegepant 75 mg Orally Dissolving Tablet for the Acute Treatment of Migraine: Results from a Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial, Study 303 (Presentation #IOR05)
Presentation Date: Saturday, July 13
Presentation Time: 8:40 am – 8:50 am
Poster presentation details:
All posters will be on display Thursday, July 11, 4:30 pm through Saturday, July 13, 5:00 pm.
The following posters will have a Q&A session on Friday, July 12, 1:15 pm – 2:15 pm:
Rimegepant 75 mg is Effective for the Acute Treatment of Migraine Regardless of Attack Frequency: Results From 3 Phase 3 Trials (Poster #P236LB)
Acute Treatment Benefit from Oral CGRP Receptor Antagonist and Monoclonal Antibody Combination: Rimegepant 75 mg for Acute Treatment of Attacks During Preventive Therapy With Erenumab (Poster #P238LB)
The Pharmacokinetics, Safety, and Tolerability of Rimegepant 75 mg are Similar in Elderly and Nonelderly Adults: A Phase 1, Open-Label, Parallel-Group, Single-Dose Study (Poster #P240LB)
A Single Dose of Rimegepant 75 mg Provides Pain Relief and Return to Normal Function: Results from 3 Phase 3 Trials in Adults With Migraine (Poster #P242LB)
A Single Dose of Rimegepant Demonstrates Sustained Efficacy and Low Rescue Medication Use in the Acute Treatment of Migraine: Results From 3 Phase 3 Trials (Poster #P244LB)
Rimegepant 75 mg Is More Effective Than Nonsteroidal Anti-inflammatory Drugs for the Acute Treatment of Migraine: Post Hoc Analysis of Data From 2 Phase 3 Trials (Poster #P246LB)
Phase 1 Safety, Tolerability and Pharmacokinetics of Single and Multiple Dose Rimegepant as Compared to the Predicted Clinically Efficacious Dose Range (Poster #P280LB)
The following posters will have a Q&A session on Saturday, July 13, 1:00 pm – 2:15 pm:
Rimegepant 75 mg Demonstrates Superiority to Placebo on Nausea Freedom: Results from a Post Hoc Pooled Analysis of 3 Phase 3 Trials in the Acute Treatment of Migraine (Poster #P41)
Long-Term, Open-Label Safety Study of Rimegepant 75 mg for the Treatment of Migraine (Study 201): Interim Analysis of Safety and Exploratory Efficacy (Poster #P235LB)
Cardiovascular Safety of Rimegepant 75 mg in 3 Randomized Clinical Trials and Systematic Evaluations from In Vitro, Ex Vivo, and In Vivo Nonclinical Assays (Poster #P237LB)
Rimegepant is Effective for the Acute Treatment of Migraine in Subjects Taking Concurrent Preventive Medication: Results From 3 Phase 3 Trials (Poster #P239 LB)
Rimegepant 75 mg in Subjects with Hepatic Impairment: Results of a Phase 1, Open-label, Single-dose, Parallel-Group Study (Poster #P241LB)
The Safety and Tolerability of Rimegepant 75 mg Are Similar to Placebo: Results from 3 Phase 3 Trials in Adults With Migraine (Poster #P243LB)
Rimegepant Has No Clinically Relevant Effects on ECG Parameters: A Thorough QT Study Versus Placebo and Moxifloxacin in Healthy Subjects (Poster #P245LB)
Safety of Rimegepant 75 mg in Adults With Migraine: No Effects of Age, Sex, or Race in 3 Phase 3 Trials (Poster #P247LB)
About Rimegepant
Rimegepant is Biohaven’s orally-dosed calcitonin gene-related peptide (CGRP) receptor antagonist, which the Company is developing as a treatment for migraine. Rimegepant represents a novel mechanism that targets the underlying pathophysiology of migraine without causing vasoconstriction. The efficacy and safety profile of rimegepant for the acute treatment of migraine has now been established across four randomized controlled trials to date: the three completed pivotal Phase 3 trials, and a Phase 2b trial. The co-primary endpoints achieved in all three Phase 3 trials are consistent with regulatory guidance from the FDA and form the basis of Biohaven’s NDA submission to the FDA.
About Biohaven
Biohaven is a clinical-stage late-stage disorders. Biohaven has combined internal development and research with intellectual property licensed from companies and institutions including Bristol-Myers Squibb Company, AstraZeneca AB, Yale University, Catalent, ALS Biopharma LLC and Massachusetts General Hospital. Currently, Biohaven’s lead development programs include multiple compounds across its CGRP receptor antagonist, glutamate modulation and myeloperoxidase inhibition platforms. More information about Biohaven is available at www.biohavenpharma.com .
Forward-Looking Statements
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Company’s management. All statements, other than statements of historical facts, included in this press release regarding the Company’s business and product candidate plans and objectives are forward-looking statements. Forward-looking statements include those related to: the expected timing, commencement and outcomes of the Company’s planned and ongoing clinical trials, the timing of planned interactions and filings with the FDA, the timing and outcome of expected regulatory filings, the expected issuance of preferred stock to Royalty Pharma, the potential commercialization of the Company’s product candidates and the potential for the Company’s product candidates to be first in class or best in class therapies. The use of certain words, including “believe”, “continue”, “may”, “on track”, “expects” and “will” and similar expressions, are intended to identify forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K Commission on February 28, 2019. The forward-looking statements are made as of this date and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
For further information, contact Dr. Vlad Coric, Chief Executive Officer, at Vlad.Coric@biohavenpharma.com

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Yes! I’m currently 15w5d but I’ve had bad headaches and migraines for awhile now. It’s common and most likely due to hormones. Mine is typically really bad and lasts long when my allergies act up or if I’m getting a little bit of a cold. I take Tylenol and sometimes use this migraine stick that has therapeutic peppermint, lavender, and spearmint essential oils with a base of coconut oil to dilute it! It helps a lot of immediate relief while waiting for Tylenol to help.

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5 signs you should seek medical treatment for your headache

2019-06-21T14:49:07 (BPT) – You’ve been there before — you wake up and immediately feel the pulsing in your head, you get to work and can feel the pounding pressure mounting as you move between looking at your computer screen and meetings, you’re gearing up for a fun day out with your kids but you cringe as the pain in your head magnifies with every shout of excitement.
The National Headache Foundation wants you to know you are not alone. Nearly 40 million Americans experience migraine and the World Health Organization lists headache disease as the third leading cause of productivity loss due to disability.
“People often underestimate the pain they experience and think their only choice is to endure,” said Dr. Seymour Diamond, executive chair and founder of the National Headache Foundation and Director Emeritus and Founder of the Diamond Headache Clinic. “There is nothing normal about pain in your head, yet even today after treating headache and migraine for over 60 years, I still see doctors dismissing their patients’ symptoms.”
It can be easy to dismiss a headache as normal, but normal shouldn’t be confused with common. Headaches can also be caused by your daily habits that may be easily removed from your routine or can help your doctor develop a treatment plan.
Know your headache and migraine triggers
Food is one of the more common triggers, from smoked foods to alcohol and avocados, that is often overlooked. Keep a food journal to see if you can identify patterns and triggers Weather changes, including high- and low-pressure systems For women, menstruation and hormone fluctuations or imbalance Screen time Stress and a compromised sleep schedule Headaches or uncharacteristic migraine symptoms can indicate you need medical attention. People are often reluctant to call their healthcare provider or go to the ER because they don’t want to arrive only to learn that nothing out of the ordinary is wrong.
Diamond advises, “If your symptoms are out of the ordinary for you, absolutely seek medical attention from a specialist and get help. Your headache or migraine should not keep you from living your life to its fullest.”
Common signs that you should seek medical help for your headaches
You have more than the occasional headache (more than twice a week) Your headache persists, and continues to get worse or won’t stop Your headaches interfere with your normal activities of daily life You find yourself taking pain relievers more than two days a week You take over-the-counter medications for headache relief, but the recommended dosage is not adequate Headache and migraine are serious conditions and you shouldn’t be afraid to talk to your doctor, or to seek out a certified headache expert: www.headaches.org/resources/healthcare-provider-finder . Most patients want their healthcare providers to be prepared and engaged when answering questions and be willing to educate them about their treatment options. On the other hand, healthcare providers often think that what matters most to their patients is expressing understanding and compassion. Diamond emphasized both a patient and their healthcare provider need to communicate clearly to effectively treat the headache or migraine.
Simple steps you can take to effectively communicate your concerns and needs with your healthcare provider include: staying focused on the most important questions you have, providing a daily record of your symptoms, sharing your concerns and reactions, and asking questions. After consulting with you to best understand your personal experience and needs, your doctor may recommend a combination of treatments that may or may not include:
Pharmaceutical therapy Massage therapy Acupuncture Yoga Meditation Diet changes Exercise Sleep changes Journaling symptoms Biofeedback therapy The debilitating effects of headache and migraine don’t have to be part of your regular routine. Understanding your condition, knowing your triggers and having an honest conversation with your healthcare provider can help you get back to living your life.
For more information about headache and migraine or to find help, visit: www.headaches.org .

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What it’s like to experience “migraine with aura,” a debilitating chronic health condition

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June is Migraine Awareness Month.
It was Christmas Day 2012. My friend and I had just sat down for turkey served with a side of cheesy Hallmark holiday movies when I felt my left hand start tingling. It crept up until my whole arm was numb, while I simultaneously lost sensation on the left side of my face. The numbness slid down to my neck and as I started to lose feeling inside my throat, I was terrified I wouldn’t be able to breathe for much longer.
My friend, who suffers countless food allergies, bolted to get me an antihistamine, which appeared to relieve the numbness and within 30 minutes all was back to normal—until a pounding migraine set in. It kept me in bed for the next two days.
I had never suffered headaches before, and it was four years before it happened again, late one night while home alone and panicking about who (and how) to call if my airway became numb again. This time, I stood in the kitchen thinking I was going mad because I couldn’t see my right arm in my peripheral vision like I could the left. I then lay in bed desperately racking my brain to remember where my friend lived. “It’s New-something Beach,” I told myself over and over, baffled at why I couldn’t remember something I knew I’d never forget. (It’s Newport Beach, for the record.)
Two days later a “tele-doc” assured me I was fine. It was partly laziness, partly work, and partly the same feeling I still experience today that stopped me going to my actual doctor. Once the symptoms hit, time stops. I wallow in frustration, self-pity, and sometimes even tears. Yet, once the worst passes, I find myself questioning whether it was actually that bad or if I was just being a drama queen given that I can function now, albeit with a lingering headache.
When I did finally see my doctor, after several more incidents of visual disturbances followed by excruciating migraines—three times in a week at one point—she immediately diagnosed me with migraines with aura, ordered an MRI (which was clear) and referred me to a neurologist.
According to the American Migraine Foundation , migraines affect 12% of the population (around 39 million Americans) and between 25-30% of patients suffer aura—defined as a a sensory disturbance—which indicates that an astronomical 9+ million people are suffering migraines with aura in the U.S. alone. The sensory disturbances can include blind spots, speech difficulty, numbness, and confusion, and the trippy nature of the visual disturbances is said to have inspired famous pieces of art. Aura typically lasts 20-60 minutes before a migraine kicks in, although some patients suffer aura without subsequent head pain.
“We believe that cortical spreading depression is the reason why you have an aura,” says Dr. Cathy Glaser of the Migraine Research Foundation , which raises money to fund research, improve treatments, and finds causes and cures for migraines. “It’s an electrical force that goes through your brain and the result is aura. What causes that is still unknown.”
So, with well over 1 billion people estimated to be experiencing aura worldwide, why had neither myself nor most people I know heard of aura in a medical sense? “I think it’s largely undiagnosed,” Dr. Glaser says. “And if you don’t know that’s what you’re suffering, you’re not going to talk about it.”
Women are bearing the brunt of migraines, a genetic neurological disease. The Migraine Research Foundation states that 28 million (out of 39 million) migraine sufferers are women , with an increased occurrence during the reproductive years, which makes me—a 37-year-old woman with a mother who suffered migraines (without aura) in her forties—a prime candidate.
My neurologist’s first suggestion was to stop drinking coffee for a month. “Ha!” I thought. “As if.” Caffeine helps alleviate migraine pain, but is less effective if your system is used to it, he said. For a month, I reluctantly sipped the various flavors of hot chocolate I bought to justify my new and unwanted habit, instead of the extra-strength espresso I bring back in bulk every time I go home to New Zealand. I didn’t suffer any migraines to test the theory that the drugs would be more effective and promptly resumed my caffeine habit when the month was over, given that I’ve had it two decades and gone years without migraines.
In the year since, I’ve experienced migraines anywhere from every two weeks to once in four months, and they’ve followed a consistent pattern of blind spots and visual disturbances before a pounding migraine lasting 8-12 hours, but often lingering for days. Numbness and confusion haven’t haunted me again, however recent episodes have seen me hit with a second round of aura 12 hours after the first, followed by an even more intense head-pounder.
Although I’m sometimes guilty of staying on my laptop, common advice is to lie in a dark room until aura passes. My neurologist prescribed Excedrin with caffeine and Tylenol to take at the onset of symptoms, and sumatriptan for when the migraine starts to set in, however the pill makes me nauseous and it’s difficult to know whether it’s easing my pain or if I’m experiencing a less intense migraine. I’ve found codeine to be more effective for pain management, and on my worst days have taken all of the above.
The Aculief (a small device placed between your thumb and forefinger to apply pressure to the L14 acupressure point) seemingly helped ease pain during one episode, but again, it’s hard to know whether treatments are working or if it’s just a lesser migraine, and ultimately my most effective move has been sleeping it off. The FDA recently approved a device that uses smartphone-controlled electronic pulses to relieve migraine pain.
As for preventive measures, magnesium supplements keep aura at bay for some, while 2018 saw the arrival of Emgality , belonging to a class of drugs called CGRP inhibitors, which aim to reduce the frequency of migraines. The monthly injections have a list price of $6,900 a year and a common theme in reviews is that they are painful, but effective.
For Jennifer O’Neil, the injections have been life-changing, having suffered “debilitating” migraines since she was 6. Her aura took the form of “everything smelling like skunk,” and she averaged 12-15 incidents per month until starting Emgality in December. She’s had only three migraines since, and none since March. Aside from pain and a rash at her injection site, the treatment has given her new life, with triggers like irregular sleep, chocolate, and travel no longer a problem. “I experienced so much anxiety because the simplest things would trigger migraines,” she says. “Now, I feel like I can take on the world. I’ve been told I’m a ‘glass half-empty’ girl, and some of that has definitely lifted. When you’re not in constant pain with a deep-seated fear hanging over your head, it’s freeing.”
Others swear by Botox, an FDA-approved method for those who suffer chronic migraines (more than 15 days per month.) The Botox is injected around pain fibers in the head and stops chemicals involved in pain transmission from being released.
Maureen Dooley suffered migraines with aura multiple times a week or day until getting Botox. “I’ve been free of them for over 15 months and get the injections every four or so months,” she says.
“Any drug that helps your migraine is life-changing, but Botox in particular because it eliminates or significantly decreases the need to take other medication for a long period since it lasts 3-4 months,” Dr. Glaser says.
She notes that like with any other treatment, neither Emgality nor Botox will work for everyone and adds that general healthy habits, like consistent sleep patterns, regular meals, and managing anxiety can make a huge difference. “It’s not going to make migraines go away, but will help you manage them.”
Pain and inconvenience of migraines aside, one of the worst parts has been worrying when the next one will hit. The unpredictability carries an often-unshakeable fear, and an endless string of “what ifs.” What if I walk into a bucket list celebrity interview and confusion hits? What if I get married and experience visual problems right before walking down the aisle? What if I’m driving and numbness occurs? Having gone three months without a migraine, the tiniest glitch in my vision ignites a wave of dread that the auras are back.
I often feel unjustified for taking a sick day or cancelling plans because of what so many ears hear as “just a headache.” Or, I feel silly for whining about my symptoms when I know there are people out there battling life-threatening conditions, or migraine patients suffering worse and more frequently than myself.
Take Melissa Phelps—she’s 38 and has been suffering since she was 12 years old. “I was looking at the teacher and her face suddenly disappeared,” she recalls. “I was scared so I went to the sick bay at which point the left side of my face went numb and I started vomiting.” An MRI ruled out doctors’ stroke suspicions and Melissa was told it was a migraine with aura, which she continued to suffer weekly or monthly for the next few years, during which she relied on imigran nasal spray for relief.
While eventually going aura-free, the weekly bouts returned as she started planning her wedding at 21, and they became daily after she got pregnant later that year. Stopping after she gave birth, symptoms returned when she was expecting her second daughter at 23 and again, “worse than ever,” when her husband died. “I tried taking antidepressants, but after one month I started getting multiple auras per day,” says Phelps, who has also found codeine effective. “I was left in a financial mess and needed to work but couldn’t due to the auras. I suffered terribly until I was around 30 years old, then they stopped for a few years, which was wonderful—I started working full-time in retail and was able to travel with my beautiful daughters. Then they came back two years ago and are now daily. Maybe caused by stress… two teenage daughters!”
While Melissa’s patterns suggest stress as a contributing factor, others have found food, red wine, and menstrual cycles to be triggers. The rapid drop in the hormone estrogen prior to the start of menstruation is believed to be what ignites migraines in the days before/after periods commence, and the Migraine Research Foundation estimates 7-19% of women suffer menstrual migraines.
Between doctor’s advice, online articles, Facebook groups, and medical studies, the vast number of treatments and suggestions can be so overwhelming it’s enough to bring on another headache. I feel lucky that I don’t suffer frequently enough to thoroughly experiment with different treatments, yet not having a guaranteed solution on hand is extremely unnerving.
“Don’t give up,” Dr. Glaser advises. “There’s no magic pill for migraines, so you have to manage your expectations, be patient and persistent. Take medication enough to give it a chance to work. If it doesn’t, try the next option. If you’re not comfortable with your doctor, find someone else. There isn’t a cure right now, so you have to be realistic, take responsibility for your own care, hope for better management—and not give up!”

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