NEW HAVEN, Conn., May 18, 2020 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), announced today that it will present data from 25 accepted abstracts demonstrating the efficacy, safety, tolerability, and pharmacoeconomic value of NURTEC (rimegepant) on the 2020 American Academy of Neurology (AAN) Science Highlights virtual platform. NURTEC™ ODT (rimegepant) is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist in an orally disintegrating tablet (ODT) approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine in adults.
In lieu of an in-person annual meeting, the AAN will be showcasing accepted abstract presentations on its virtual platform, AAN.com/2020science. The virtual platform is scheduled to launch today, May 18, 2020 at 4:00 PM ET and will be open for viewing by the general public at no charge.
Vlad Coric, M.D., Chief Executive Officer of Biohaven commented, "The large number of important clinical and health economic analyses highlight Biohaven's leadership and commitment to advancing NURTEC with the goal of gaining approval as the first oral CGRP-targeting agent for both the acute and preventive treatment of migraine. The data presented add to the growing body of scientific evidence supporting NURTEC ODT as a differentiated treatment for migraine with a depth of response in several patient populations, including those who have tried triptans and those using migraine preventive treatment who are in need of effective acute therapy for breakthrough attacks."
Dr. Coric added, "NURTEC ODT is the only CGRP-targeting drug to have return to normal functioning within hours and sustained efficacy out to 48 hours after a single dose in the approved drug label. Our newly published expanded data from 1,800 patients treated up to 1 year in our safety study show reductions in migraine days after intermittent treatment of acute migraine attacks with NURTEC 75 mg. This data suggest long-term benefits on functional outcome measures, decreases in disability and reductions in migraine days when acute migraine attacks are effectively treated. We have always advocated that patients with migraine deserve new solutions and we are delivering on that promise with the broad and robust data being shared on the 2020 AAN Science Highlights virtual platform."
Notably, Biohaven will be presenting results from the rimegepant Phase 3 and long-term safety clinical trials highlighting rimegepant's rapid onset and sustained duration of action, favorable long-term safety profile, concomitant use with anti-CGRP monoclonal antibodies, efficacy in triptan-experienced patients, reduction in monthly migraine days, and improvements in productivity.
A total of 25 posters/presentations will be presented as part of the AAN virtual platform. Titles of all accepted abstracts are listed below. Key highlights include:
The full presentations will be available on the AAN Science Highlights virtual platform at AAN.com/2020science and include:
About NURTEC ODT
NURTEC™ ODT (rimegepant) is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a quick-dissolve ODT formulation that is approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine in adults. The activity of the neuropeptide CGRP is thought to play a causal role in migraine pathophysiology. NURTEC ODT is a CGRP receptor antagonist that works by reversibly blocking CGRP receptors, thereby inhibiting the biologic activity of the CGRP neuropeptide. The recommended dose of NURTEC ODT is 75 mg, taken as needed, up to once daily. For more information about NURTEC ODT, visit www.nurtec.com.
The most common adverse reaction was nausea (2% in patients who received NURTEC ODT compared to 0.4% in patients who received placebo). Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4, strong or moderate inducers of CYP3A or inhibitors of P-gp or BCRP. Avoid another dose of NURTEC ODT within 48 hours when it is administered with moderate inhibitors of CYP3A4.
Nearly 40 million people in the U.S. suffer from migraine and the World Health Organization classifies migraine as one of the 10 most disabling medical illnesses. Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity that can be associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia). There is a significant unmet need for new acute treatments as more than 90 percent of migraine sufferers are unable to work or function normally during an attack.
About CGRP Receptor Antagonism
Small molecule CGRP receptor antagonists represent a novel class of drugs for the treatment of migraine. This unique mode of action potentially offers an alternative to current agents, particularly for patients who have contraindications to the use of triptans, or who have a poor response to triptans or are intolerant to them.
NURTEC™ ODT (rimegepant) is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use
NURTEC ODT is not indicated for the preventive treatment of migraine.
Important Safety Information
Contraindications: Hypersensitivity to NURTEC ODT or any of its components.
Warnings and Precautions: If a serious hypersensitivity reaction occurs, discontinue NURTEC ODT and initiate appropriate therapy. Serious hypersensitivity reactions have included dyspnea and rash, and can occur days after administration.
Adverse Reactions: The most common adverse reaction was nausea (2% in patients who received NURTEC ODT compared to 0.4% in patients who received placebo). Hypersensitivity, including dyspnea and rash, occurred in less than 1% of patients treated with NURTEC ODT.
Drug Interactions: Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4, strong or moderate inducers of CYP3A or inhibitors of P-gp or BCRP. Avoid another dose of NURTEC ODT within 48 hours when it is administered with moderate inhibitors of CYP3A4.
Use in Specific Populations:
Please click here for full Prescribing information.
You are encouraged to report side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088 or report side effects to Biohaven at 1-833-4Nurtec. Please click here for full Prescribing information and Patient Information.
Biohaven is a biopharmaceutical company focused on the development and commercialization of innovative best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases. Biohaven's neuroinnovation portfolio includes FDA-approved NURTEC™ ODT (rimegepant) for the acute treatment of migraine and a broad pipeline of late-stage product candidates across three distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine; glutamate modulation for obsessive-compulsive disorder, Alzheimer's disease, and spinocerebellar ataxia; and myeloperoxidase (MPO) inhibition for multiple system atrophy and amyotrophic lateral sclerosis. For more information, visit www.biohavenpharma.com.
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "believe", "continue", "may", "will" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Biohaven's management about NURTEC ODT as an acute treatment for patients with migraine and potential preventive treatment for migraine. Factors that could affect these forward-looking statements include those related to: Biohaven's ability to effectively commercialize NURTEC ODT, delays or problems in the supply or manufacture of NURTEC ODT, complying with applicable U.S. regulatory requirements, the expected timing, commencement and outcomes of Biohaven'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 potential commercialization of Biohaven's product candidates, the potential for Biohaven's product candidates to be first in class or best in class therapies and the effectiveness and safety of Biohaven's product candidates. 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 Biohaven's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission on February 26, 2020 and Biohaven's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, filed with the Securities and Exchange Commission on May 7, 2020. The forward-looking statements are made as of this date and Biohaven 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.
Vlad Coric, M.D.
Chief Executive Officer
Sam Brown Inc.
NURTEC is a trademark of Biohaven Pharmaceutical Holding Company Ltd.
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