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.
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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