NEW HAVEN, Conn., June 16, 2020 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN), today announced
that it presented data from 25 accepted abstracts demonstrating the
efficacy, safety, tolerability and pharmacoeconomic value of
NURTEC™ (rimegepant) at the 2020 American Headache Society
(AHS) Virtual Annual Scientific Meeting.
In lieu of an in-person annual meeting, the AHS has decided to
present portions of the Annual Scientific Meeting via a Virtual
Meeting platform, which launched Saturday,
June 13.
Elyse Stock, M.D., Chief Medical
Officer of Biohaven commented, "The extensive data set presented at
the AHS Virtual Annual Meeting showcases the important benefits
that NURTEC brings to patients. The growing body of data
continues to validate the rapid and durable efficacy of single dose
NURTEC and safety in subpopulations with significant unmet need
including people with cardiovascular risk and those who are
currently taking preventive treatments for migraine."
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.
Rimegepant has also demonstrated efficacy in the preventive
treatment of migraine and Biohaven is committed to advancing
rimegepant as a "dual-acting" therapy with the goal of gaining
approval as the first oral CGRP-targeting agent for both the acute
and preventive treatment of migraine. In December 2019, the Company also announced
positive topline results for its Phase 2/3 trial for vazegepant
(BHV-3500), the first small molecule CGRP receptor antagonist to be
administered in an intranasal formulation for the acute treatment
of migraine.
Biohaven has one oral and 24 poster presentations that are being
showcased as part of the AHS virtual platform. Key highlights
include:
Oral Presentation
- Rimegepant 75 mg Provides Early and Sustained Relief of
Migraine With a Single Oral Dose: Results from 3 Phase 3
Clinical Trials
Poster Presentations
- 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
- 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 (Study 201)
- Lost-time is Associated with Total Health Care and
Pharmaceutical Costs – A US-Based Real World Longitudinal
Analysis
- MIDAS Disability Grades are Associated with Total Health Care
and Pharmaceutical Costs – A US-Based Real World Longitudinal
Analysis
A full list of presentations can be accessed here.
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. Nurtec ODT is
not indicated for the preventive treatment of migraine. 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.
NURTEC ODT has a relatively rapid Tmax (1.5 hours) and relatively
long half-life (11 hours) which may account for rapid and sustained
efficacy demonstrated with statistically significant improvement vs
placebo on pain relief and ability to function normally at 60
minutes and sustained through 48 hours. 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.
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. The most common adverse reaction was nausea (2% in patients
who received NURTEC ODT compared to 0.4% in patients who received
placebo).
About Migraine
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.
Indication
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:
- 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. Please click here for full Prescribing
information and Patient Information.
About Biohaven
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.
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",
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 Biohaven's Annual Report on Form 10-K
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.
Biohaven Contact:
Vlad Coric, M.D.
Chief Executive Officer
Vlad.Coric@biohavenpharma.com
Media Contact:
Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502
NURTEC is a trademark of Biohaven Pharmaceutical Holding Company
Ltd.
Copyright © 2020 Biohaven. All rights reserved.
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.