NEW HAVEN, Conn., Sept. 9, 2021 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), today announced that 17 abstracts, including three late-breaking presentations and four oral presentations, will be shared at the 2021 International Headache Society – European Headache Federation Joint Congress virtually from September 8-12, 2021.

(PRNewsfoto/Biohaven Pharmaceutical Holding)

Biohaven will be presenting most recent data for its migraine portfolio including Nurtec® ODT (rimegepant) orally dissolving tablets 75 mg, the first and only calcitonin gene-related peptide (CGRP) receptor antagonist in an orally disintegrating tablet (ODT) approved by the FDA for the acute treatment of migraine and the preventive treatment of episodic migraine in adults; and intranasal zavegepant, the only intranasal CGRP receptor antagonist currently in late-stage clinical trials for the acute treatment of migraine.

The rimegepant studies include two late breaking abstracts and two oral presentations spotlighting the efficacy and safety data for rimegepant as an acute and preventive treatment of migraine. One poster showcases Phase 2/3 data for rimegepant and other highlights several health economics and outcomes research analyses including a late breaking oral lecture on time to monthly migraine days (MMDs) reduction.

Elyse Stock, MD, Chief Medical Officer of Biohaven commented, "Nurtec ODT has changed the treatment paradigm for migraine with an easy to use, oral CGRP antagonist that is now indicated for both the acute treatment and prevention of migraine. Our research efforts to help people with migraine are demonstrated by the breadth of posters presented at the 2021 International Headache Congress. Our focus remains strong on analyzing the burden of migraine and our health economics and outcomes research analysis spotlights important issues affecting those living with this debilitating disease."

Notable highlights include:

  • Data from a Phase 2/3 clinical trial to evaluate the safety and efficacy of rimegepant as a preventive treatment of migraine compared to placebo demonstrated that oral rimegepant taken every other day showed rapid migraine preventive effects as early as the first week of dosing. Additionally, it was observed to be superior to placebo across both primary and secondary endpoints of the trial. These include ≥50% reduction in the mean number of moderate or severe MMDs during weeks 9-12 (49% vs 41%, p=0.0438) and change in the mean number of total MMDs during Weeks 1-12 (−4.3 vs −3.5, p=0.0099).
  • Results from an open label safety study of rimegepant demonstrated its preventive benefits when dosed on an as needed basis to treat migraine attacks, expressed as median time to 30% and 50% reduction in MMDs observed to decrease at 12 weeks and 32 weeks respectively. Additionally, the long-term use of rimegepant 75 mg was associated with reductions in MMDs without evidence of medication-related increases in headache frequency. A different analysis that evaluated the safety of rimegepant in those with cardiovascular (CV) risk showed that rimegepant dosed up to once daily for up to 1 year showed favorable safety and tolerability in adults with migraine with CV risk factors, including adults with moderate to high CV risk.
  • A long-term open label safety study assessed patient preference, satisfaction, and improved clinical global impression of change (CGI-C) with rimegepant 75 mg for the acute treatment of migraine. Data showed that at week 24, 78.7% of subjects preferred rimegepant over their previous migraine medications, 89.4% of subjects were satisfied with rimegepant, and 88.8% of subjects were considered improved since study entry on the CGI-C scale. Among individuals using rimegepant as an acute treatment for one year, four in five preferred rimegepant to their previous migraine medications, seven in 10 were satisfied with rimegepant, and nine in 10 experienced clinical improvement relative to baseline.
  • A U.S.-based real world longitudinal analysis showed that migraine-related absenteeism was common, affecting more than two-thirds of the analyzed cohort and was associated with higher medical and pharmaceutical claims and healthcare costs. The analysis evaluated migraine-related absenteeism and its association with healthcare utilization and cost among adults with migraine.
  • A Phase 2/3 dose-ranging study evaluating the safety, efficacy and tolerability of intranasal zavegepant for the acute treatment of migraine demonstrated that zavegepant 10 mg and 20 mg were superior to placebo on the coprimary endpoints of pain freedom [placebo: 15.5%; 5 mg: 19.6% (p=0.1214); 10 mg: 22.5% (p=0.0113); 20 mg: 23.1% (p=0.0055)] and most bothersome symptom [placebo: 33.7%; 5 mg: 39.0% (p=0.1162); 10 mg: 41.9% (p=0.0155); 20 mg: 42.5% (p=0.0094)] at two hours post dose. The most common (>5%) adverse events (AEs) with zavegepant were altered taste (13.5%-16.1% vs 3.5% with placebo) and nasal discomfort (1.3%-5.2% vs 0.2% with placebo).

The complete list of accepted abstract titles is below and full presentations will be available to registered participants on the Congress website beginning September 8, 2021.

Oral Presentations:

  • (Late-breaker) Acute Treatment with Rimegepant 75 mg Confers Long Term Improvements in Median Time to 30% and 50% Reductions in Monthly Migraine Days – Post Hoc Results from an Open Label Safety Study (BHV3000-201)
  • Onset of Migraine Preventive Effects With Rimegepant in a Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Trial
  • A Phase 2/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant for the Preventive Treatment of Migraine
  • Migraine-Related Absenteeism is Associated With Total Healthcare and Pharmaceutical Costs — A US-Based Real World Longitudinal Analysis

Poster Presentations:

  • (Late-breaker) Understanding the Patient Experience and Disease Burden of Migraine: a Qualitative Interview Study
  • (Late-breaker) Effect of Strong P-gp and BCRP Inhibition, Using Cyclosporine and Quinidine as Probes, on the Pharmacokinetics of Oral Rimegepant 75 mg in Healthy Subjects 
  • Oral Rimegepant 75 mg is Safe and Well Tolerated in Adults With Migraine and Cardiovascular Risk Factors: Results of a Multicenter, Long-Term, Open-Label Safety Study 
  • Acute Treatment with Oral Rimegepant 75 mg Reduces Migraine-Related Disability in Adults With and Without a History of Triptan Treatment Failure: Results from a One Year, Open-Label Safety Study 
  • Acute Treatment of Migraine With Rimegepant Improves Health Related Quality of Life in Adults With a History of Triptan Treatment Failure: Results from a Long-Term, Open-Label Safety Study
  • Long-term Use of Rimegepant 75 mg for the Acute Treatment of Migraine Reduces Use of Analgesics and Antiemetics 
  • Rimegepant for the Acute Treatment of Migraine: Subgroup Analyses From 3 Phase 3 Clinical Trials by Number of Triptans Previously Tried and Failed
  • Patient Preference, Satisfaction, and Improved Clinical Global Impression of Change with Rimegepant 75 mg for the Acute Treatment of Migraine: Results from a Long-Term Open-Label Safety Study
  • Rimegepant 75 mg for the Acute Treatment of Migraine in Adults With Frequent Migraine: Long-Term Safety and Clinical Improvement Versus Baseline
  • Rimegepant Versus Atogepant and Monoclonal Antibody Treatments for the Prevention of Migraine: A Systematic Literature Review and Network Meta-analysis 
  • Monthly Migraine Days, Tablet Utilization, and Quality of Life Associated with Rimegepant – Post Hoc Results from an Open Label Safety Study (BHV3000-201)
  • Intranasal Zavegepant is Effective and Well Tolerated for the Acute Treatment of Migraine: A Phase 2/3 Dose-Ranging Clinical Trial
  • Economic Modeling of Migraine Prevention Therapies: Considerations for Current and Emerging Therapies

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 with or without aura and the preventive treatment of episodic 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 to treat or every other day to help prevent migraine attacks. For more information about NURTEC ODT, visit www.nurtec.com. The most common adverse reaction was nausea and abdominal pain/indigestion. 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.

Indication
NURTEC ODT orally disintegrating tablets is a prescription medicine that is used to treat migraine in adults. It is for the acute treatment of migraine attacks with or without aura and the preventive treatment of episodic migraine. It is not known if NURTEC ODT is safe and effective in children.

Important Safety Information
Do not take NURTEC ODT if you are allergic to NURTEC ODT (rimegepant) or any of its ingredients.  

Before you take NURTEC ODT, tell your healthcare provider (HCP) about all your medical conditions, including if you: 

  • have liver problems,
  • have kidney problems,
  • are pregnant or plan to become pregnant,
  • breastfeeding or plan to breastfeed.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

NURTEC ODT may cause serious side effects including allergic reactions, including trouble breathing and rash. This can happen days after you take NURTEC ODT. Call your HCP or get emergency help right away if you have swelling of the face, mouth, tongue, or throat or trouble breathing. This occurred in less than 1% of patients treated with NURTEC ODT.

The most common side effects of NURTEC ODT were nausea (2.7%) and stomach pain/indigestion (2.4%). These are not the only possible side effects of NURTEC ODT. Tell your HCP if you have any side effects.

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.

About Zavegepant
Zavegepant is a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist from Biohaven's NOJECTION™ Migraine Platform and the only CGRP receptor antagonist in clinical development with both intranasal and oral formulations. The efficacy and safety profile of intranasal zavegepant for the acute treatment of migraine, as compared to placebo, was shown in a randomized controlled Phase 2/3 dose-ranging trial with a total of over 1000 patients who received zavegepant. In this study, zavegepant showed statistical superiority to placebo on the coprimary endpoints of 2 hour freedom from pain and freedom from a patients' most bothersome symptom (either nausea, photophobia or phonophobia). Following successful end of Phase 2 interactions with FDA (clinical and nonclinical), zavegepant is advancing to Phase 3 for the acute treatment of migraine in adults. For more information, visit https://www.biohavenpharma.com/science-pipeline/cgrp/bhv-3500.

About Biohaven
Biohaven is a commercial-stage biopharmaceutical company with a portfolio of innovative, best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases, including rare disorders. Biohaven's neuroinnovation portfolio includes FDA-approved NURTEC ODT (rimegepant) for the acute and preventive 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 and CGRP-mediated neuroimmune/neuroinflammatory diseases; glutamate modulation for obsessive-compulsive disorder, Alzheimer's disease, and spinocerebellar ataxia; and myeloperoxidase (MPO) inhibition for multiple system atrophy and amyotrophic lateral sclerosis. More information about Biohaven is available at www.biohavenpharma.com.

Forward-looking Statement
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 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 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, 2020, filed with the Securities and Exchange Commission on March 1, 2021, and in Biohaven's subsequent filings with the Securities and Exchange Commission. 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.

NURTEC and NURTEC ODT are registered trademarks of Biohaven Pharmaceutical Ireland DAC. Neuroinnovation is a trademark of Biohaven Pharmaceutical Holding Company Ltd.

Biohaven Contact
Dr. Vlad Coric
Chief Executive Officer
Vlad.Coric@biohavenpharma.com

Media Contact
Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502

 

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