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:
- Concomitant use of rimegepant with anti-CGRP mAbs was evaluated
in a subgroup of patients in the rimegepant long-term safety study.
Thirteen patients who experienced 2-8 moderate-to-severe monthly
attacks while taking a stable dose of an FDA-approved anti-CGRP mAb
were included and instructed to treat attacks of any pain intensity
with oral rimegepant 75 mg as needed up to once daily for 12 weeks.
The study demonstrated favorable tolerability and no safety issues
when using rimegepant as an oral acute treatment in adults with
migraine while also receiving an injectable anti-CGRP mAb
preventive treatment.
- A pooled analysis from three Phase 3 clinical trials evaluated
the efficacy of rimegepant 75 mg in patients who had a history of
triptan treatment failure or who were using triptans at the time of
trial enrollment. Results demonstrated that in both groups of
triptan-experienced patients, rimegepant was more effective than
placebo on pain freedom, MBS freedom, and pain relief at 2 hours
post-dose as well as other clinically meaningful secondary
endpoints.
- Pooled results from three Phase 3 clinical trials with 3,507
patients (rimegepant n=1749, placebo n=1758) evaluating the
efficacy of rimegepant for the acute treatment of migraine showed
that a single oral dose of rimegepant 75 mg without repeat dosing
or rescue medication was superior to placebo for sustained pain
relief and ability to function normally from 2 to 48 hours
post-dose. Additionally, rapid onset of action was demonstrated
with rimegepant ODT with some patients experiencing pain relief as
early as 15 minutes post-dose; effects were statistically superior
to placebo on pain relief and ability to function normally at 60
minutes post-dose.
- A pooled, post-hoc analysis of long-term safety data
demonstrated that acute treatment of migraine with rimegepant 75 mg
provides significant improvements to absenteeism (ABS),
presenteeism (PBS), and improves lost productivity time (LPT) by
44% (~11 fewer days per month) reflecting improvements in workplace
productivity. In the study, patients were instructed to treat
migraine attacks of any pain intensity with up to one dose of
rimegepant 75 mg as needed, up to once daily, for 52 weeks. ABS,
PRE and LPT were assessed at baseline and at weeks 12, 24, 36, and
52 using the validated Migraine Disability Assessment
instrument.
- Results from post-hoc, pooled analysis of long-term safety data
showed a reduction in monthly migraine days (MMD) across three
rimegepant patient groups (n=1,800): Group 1 had 2-8 MMD and
received as needed dosing (PRN), Group 2 had 9-14 MMD and also
received PRN, and Group 3 had 4-14 MMD and dosed every other day
(QOD) plus PRN. Results showed that treatment with rimegepant 75 mg
was associated with notable reductions in MMD. The magnitude of MMD
reduction was associated with the range of reported historic
migraine frequency and the migraine frequency assessed during the
30-day pre-treatment observation period.
The full presentations will be available on the AAN Science
Highlights virtual platform at AAN.com/2020science and
include:
- Rimegepant is Effective for the Acute Treatment of Migraine in
Patients with a History of Triptan Treatment Failure: Pooled
Analyses from 3 Phase 3 Clinical Trials
- Oral Rimegepant 75 mg is Well-tolerated When Used Concomitantly
with Injectable Anti-CGRP Monoclonal Antibodies: Results From a
Multicenter, Long-term, Open-label Safety Study
- Rimegepant 75 mg Provides Early and Sustained Relief of
Migraine With a Single Dose: Results from 3 Phase 3 Clinical
Trials
- Patient Preference and Improved Clinical Global Impression of
Change with Rimegepant for the Acute Treatment of Migraine: Results
from a Long-Term Open-Label Safety Study (Study 201)
- Long-Term Safety of Rimegepant 75 mg for the Acute Treatment of
Migraine (Study 201)
- Acute Treatment of Migraine with Oral Rimegepant 75 mg Confers
Robust Improvement in Absenteeism, Presenteeism and Productivity:
Results from a One Year, Open-Label, Safety Study
(BHV3000-201)
- Rimegepant 75 mg Results in Reductions in Monthly Migraine
Days: Secondary Analysis of a Multicenter, Open Label Long-term
Safety Study of Rimegepant for the Acute Treatment of Migraine
- Comparative Efficacy and Safety of Rimegepant Versus Ubrogepant
and Lasmiditan for Acute Treatment of Migraine: A Network
Meta-analysis (NMA)
- Matching-adjusted Indirect Comparisons of Intermittent Oral
Rimegepant Versus Placebo and Injectable anti-CGRP Monoclonal
Antibodies (mAb) Examining Health-related Quality of Life
(HRQoL).
- Matching-adjusted Indirect Comparisons of Intermittent Oral
Rimegepant Versus Placebo and Injectable anti-CGRP-targeted
Monoclonal Antibodies Examining Monthly Migraine Days in the
Treatment of Migraine
- Migraine Patients Exhibit Increased Relative Risk for
Medication Overuse Headache with Sustained Triptan Treatment -
Results from a Real-World Claims Analysis
- Switching and Discontinuation Patterns Among Triptan Users: A
Systematic Literature Review
- Acute Treatment of Migraine with Oral Rimegepant 75 mg Improves
Health Related Quality of Life: Results from a Long-Term,
Open-Label Safety Study (BHV3000-201)
- Acute Treatment with Oral Rimegepant 75 mg Reduces
Migraine-Related Disability: Results from a One Year, Open-Label
Safety Study (BHV3000-201)
- Cardiovascular Safety of Rimegepant 75 mg in 3 Randomized
Clinical Trials and Systematic Evaluations from In Vitro, Ex Vivo,
and In Vivo Nonclinical Assays
- Rimegepant is Effective for the Acute Treatment of Migraine in
Subjects Taking Concurrent Preventive Medication: Results From 3
Phase 3 Trials
- Rimegepant 75 mg is Effective for the Acute Treatment of
Migraine Regardless of Attack Frequency: Results From 3 Phase 3
Trials
- Rimegepant 75 mg Demonstrates Superiority to Placebo on Nausea
Freedom: Results from a Post Hoc Pooled Analysis of 3 Phase 3
Trials in the Acute Treatment of Migraine
- Rimegepant 75 mg Demonstrates Safety and Tolerability Similar
to Placebo With No Effects of Age, Sex, or Race in 3 Phase 3
Trials
- Rimegepant 75 mg Is More Effective for Migraine Than
Nonsteroidal Anti-inflammatory Drugs: Post Hoc Analysis of Data
From 2 Phase 3 Trials
- Phase 1 and 2 Safety, Tolerability and Pharmacokinetics of
Single and Multiple Dose Rimegepant as Compared to the Predicted
Clinically Efficacious Dose Range
- Oral Rimegepant Produces No Significant Effect on Blood
Pressure When Administered Concomitantly with SC Sumatriptan
- Rimegepant has No Clinically Relevant Effect on ECG parameters
at Therapeutic and Supratherapeutic Doses: A Thorough QT Study
Versus Placebo and Moxifloxacin in Healthy Subjects
- Results of a Phase 1, Open-label, Single-dose, Parallel-group
Study of Rimegepant 75 mg in Subjects with Hepatic Impairment
- Rimegepant 75 mg Exposure, Safety, and Tolerability are Similar
in Elderly and Nonelderly Adults: a Phase 1, Open-Label,
Parallel-Group, Single-Dose Study
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.
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 Statements
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.
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.