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- Pivotal trial of rimegepant for the preventive treatment of migraine spotlights reduction of 4.3 monthly migraine days during weeks 9-12 and rapid onset of preventive effects observed within the first week of treatment
- Post-hoc analysis of rimegepant in the acute treatment of migraine dosed on an as needed (p.r.n.) basis demonstrated clinically relevant reductions in monthly migraine days over time
- Intranasal zavegepant pivotal Phase 2/3 trial met co-primary endpoints and demonstrated rapid onset of action with pain relief as early as 15 minutes
- Spinocerebellar ataxia study suggests an attenuation of disease progression in patients treated with troriluzole in a 96-week open label extension protocol
- Additional new and encore oral presentations and posters demonstrate advancements across multiple clinical programs including Nurtec® ODT (rimegepant), zavegepant, verdiperstat and troriluzole
NEW HAVEN, Conn., April 13, 2021 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), today announced that 22 abstracts, including three oral presentations, were accepted at the 2021 American Academy of Neurology (AAN) virtual annual meeting being held from April 17 – 22. The abstracts are available on the AAN website at https://index.mirasmart.com/AAN2021/.
Biohaven will be presenting new data analyses of the company's FDA-approved acute treatment for migraine in adults, Nurtec® ODT (rimegepant) that show its efficacy and safety for both the acute and preventive treatment of migraine, as well as multiple pipeline assets including: intranasal zavegepant for the acute treatment of migraine, troriluzole for the treatment of spinocerebellar ataxia (SCA), and verdiperstat for multiple system atrophy (MSA). Additional health economic and outcomes research analyses are also being presented that highlight the clinical utility of Nurtec ODT, the burden of migraine, and unmet needs of existing treatments.
Elyse Stock, MD, Chief Medical Officer of Biohaven commented, "The presentation of more than 20 abstracts across therapeutic areas at AAN 2021 demonstrates Biohaven's continued commitment to neuroscience research excellence across all of the company's clinical candidates. We are excited about these analyses reporting on the efficacy and safety of Nurtec ODT for the acute and preventive treatment of migraine, as well as advancements in pipeline assets including zavegepant, troriluzole, and verdiperstat. Nurtec ODT has the potential to provide a unified approach for the acute and preventive treatment of migraine and we look forward to the U.S. Food and Drug Administration's decision for this dual indication later this quarter."
Notable highlights include:
Phase 2/3 data from the pivotal randomized, placebo-controlled trial assessing rimegepant for the preventive treatment of migraine evaluated 695 patients for efficacy. Rimegepant was superior to placebo on the primary endpoint of change from the observation period in mean monthly migraine days (MMDs) during weeks 9-12 (−4.3 vs −3.5, p=0.0099) as well as on the secondary endpoint of ≥50% reduction in mean number of moderate or severe MMDs during weeks 9-12 (49% vs 41%, p=0.0438). A post-hoc analysis showed that rimegepant demonstrated rapid onset of preventive treatment efficacy with reductions in migraine days observed within the first week of every other day dosing.
Data from a Phase 2/3 dose-ranging study of intranasal zavegepant, a third-generation, high-affinity, selective and structurally unique, small molecule calcitonin gene-related peptide (CGRP) receptor antagonist - the only intranasal CGRP receptor antagonist currently in late-stage clinical trials for the acute treatment of migraine. In the study, zavegepant 10 mg and 20 mg demonstrated statistical superiority to placebo on the co-primary 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 (MBS) freedom [placebo: 33.7%; 5 mg: 39.0% (p=0.1162); 10 mg: 41.9% (p=0.0155); 20 mg: 42.5% (p=0.0094)]. Rapid onset of pain relief was also observed as early as 15 minutes.
Preliminary data from a 96-week, open-label extension phase of Phase 2b/3 study evaluating the safety and efficacy of troriluzole in adults with spinocerebellar ataxia suggested attenuation of disease progression in patients treated with troriluzole. After up to 96 weeks of open-label treatment with troriluzole, the mean change from baseline in total SARA score (mean change ± SE) was 0.3 ± 0.30. Patients who had a gap in troriluzole treatment (3 weeks to 12 months) showed a greater than 1 point worsening during the off-treatment period. This worsening increased with longer duration of time off troriluzole. Improvements in total SARA score were observed after re-initiation of troriluzole therapy.
The complete list of accepted abstract titles is below and full presentations will be available on the 2021 AAN virtual annual meeting website from April 17, 2021.
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
Intranasal Zavegepant is Effective and Well Tolerated for the Acute Treatment of Migraine: A Phase 2/3 Dose-Ranging Clinical Trial
Analysis of 96 Week, Long-Term Open Label Extension Phase of Study BHV4157-201: A Phase IIb/III, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Troriluzole in Adult Subjects with Spinocerebellar Ataxia
A Phase 2/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant for the Preventive Treatment of Migraine
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 in Patients with a History of Triptan Treatment Failure: Pooled Results From 3 Phase 3 Clinical Trials
Long-Term Safety of Rimegepant 75 mg for the Acute Treatment of Migraine in Adults With a History of Triptan Treatment Failure
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
Preference for Rimegepant and Improved Clinical Global Impression of Change Among Adults with a History of Triptan Treatment Failure: 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
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 (BHVN-3000-201)
Estimated Migraine Acute-therapy Savings from MMD Reduction Achieved with Preventive Treatment
Acute Treatment with Rimegepant 75 mg Confers Clinically Relevant Improvement in Lost Time (Days) Due to Migraine: Results From a 1-Year, Open-Label Safety Study (BHV3000-201)
Migraine Patients Exhibit Increased Risk Of Developing Chronic Migraine With Sustained Triptan Treatment - Results From A Large-Scale Real-World Claims Analysis
Low Rates of Rescue Medication Usage in Subjects Treated with a Single Dose of Rimegepant 75 mg for the Acute Treatment of Migraine: Results from 3 Phase 3 Clinical Trials
Rimegepant is Safe and Tolerable for the Acute Treatment of Migraine in Patients Using Preventive Migraine Medications: Results from a Long-Term Open-Label Safety Study
Migraine Patients Exhibit Increased Risk of Opioid Dependence with Sustained Triptan Treatment - Results from a Large-Scale Real-World Claims Analysis
Migraine Patients Exhibit Risk of Medication Overuse Headache with Sustained Triptan Treatment - Results from a Large-Scale Real-World Claims Analysis
MIDAS Disability Grades are Associated with Total Health Care and Pharmaceutical Costs – A US-Based Real World Longitudinal Analysis
Acute Migraine Medication and Medication Overuse Headache: A Systematic Literature Review
MSQ Utility Mapping of Rimegepant by Change in Monthly Migraine Days
M-STAR, an Ongoing Phase 3 Study in Participants with Multiple System Atrophy–Baseline Characteristics
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 to treat up to 15 migraine attacks in a 30-day period. 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.
NURTEC ODT 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:
Pregnant/breast feeding: It is not known if NURTEC ODT can harm an unborn baby or if it passes into breast milk.
Hepatic impairment: Avoid use of NURTEC ODT in persons with severe hepatic impairment.
Renal impairment: Avoid use in patients with end-stage renal disease.
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.
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.
Verdiperstat (BHV-3241) is an investigational first-in-class, potent, selective, brain-penetrant, and myeloperoxidase (MPO) enzyme inhibitor that Biohaven is developing for the treatment of neurodegenerative diseases. Verdiperstat may help preserve neurons through inhibition of MPO-induced pathological oxidative stress and inflammation that contribute to cellular injury in neurodegenerative diseases such as ALS and multiple system atrophy (MSA). Biohaven licensed verdiperstat (BHV-3241) from AstraZeneca in September 2018, where it was known as AZD3241. For more information about the HEALEY ALS Platform Trial, visit at www.massgeneral.org/als and clinicaltrials.gov/ct2/show/NCT04436510. Information about verdiperstat is available at www.biohavenpharma.com/science-pipeline/mpo/verdiperstat.
Troriluzole is a third-generation prodrug and new chemical entity that modulates glutamate, the most abundant excitatory neurotransmitter in the human body. The primary mode of action of troriluzole is normalization of synaptic levels of glutamate. Troriluzole increases glutamate uptake from the peri-synaptic space, by augmenting the expression and function of excitatory amino acid transporters (i.e., EAAT2 also called GLT-1) located on glial cells that play a key role in clearing glutamate from the synapse. For more information, visit https://www.biohavenpharma.com/science-pipeline/glutamate/troriluzole.
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 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 MPO inhibition for multiple system atrophy and amyotrophic lateral sclerosis. More information about Biohaven is available at 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", "may" and "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. 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 the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2021. 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.
Dr. Vlad Coric
Chief Executive Officer
Sam Brown Inc.
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