- Migraine patients treated with Nurtec ODT had a reduction in
total opioid prescriptions filled after initiation of therapy,
according to an analysis of real-world administrative
claims
- Single and multiple daily doses of intranasal zavegepant of
up to 40 mg were well tolerated in Phase 1 study
- Rimegepant, atogepant and monoclonal antibody treatments
determined to be effective options for the prevention of migraine
when compared vs placebo
NEW
HAVEN, Conn., March 31,
2022 /PRNewswire/ -- Biohaven Pharmaceutical Holding
Company Ltd. (NYSE: BHVN), today announced that 13 abstracts,
including two oral presentations, will be featured at the 2022
American Academy of Neurology (AAN) annual meeting being held
April 2-7 in Seattle, WA and virtually from April 24-26. Building on its leadership in
migraine, Biohaven is committed to advancing innovative treatments
and transforming patient experiences while focusing on research
that may drive better outcomes for people across the spectrum of
neurological diseases.
Biohaven will be sharing 13 presentations from its clinical
portfolio including Nurtec® ODT (rimegepant) and zavegepant nasal
spray along with related health economic and outcomes research
analyses that highlight real-world studies with rimegepant.
Elyse Stock, MD, Chief Medical
Officer of Biohaven commented, "The research presented at AAN 2022
represents Biohaven's continuing efforts to further advance
effective treatment options for those living with debilitating
neurological and neuropsychiatric diseases. One of our most
compelling presentations highlights Nurtec ODT's clinical utility
as demonstrated by a reduction in opioid prescriptions filled and
medication overuse headache following treatment. Nurtec ODT is the
only dual indication therapy for the acute treatment of migraine
and preventive treatment of episodic migraine in adults, and is
highly relevant in the context of today's public health needs.
Biohaven's new data highlight treatment options for migraine that
are important to patients and clinicians; a favorable efficacy and
safety profile without addictive or abuse potential. Biohaven is
presenting results from our Phase 1 study of intranasal zavegepant.
Zavegepant is the only late-stage CGRP receptor antagonist using
intranasal administration for rapid onset of action starting at 15
minutes and potential utility in patients experiencing significant
nausea/vomiting during an attack. The Phase 1 results underscore
the safety and tolerability profile of this intranasal zavegepant
and provides further support for its upcoming NDA filing."
Notable highlights include:
- Reduction in opioid use and medication overuse headache:
Two real-world administrative claims analyses evaluated reduction
in opioid use and medication overuse headache (MOH) prior to and
following use of Nurtec ODT initiation. Results demonstrated a
significant reduction in opioid use, measured by mean monthly fills
and mean monthly MME dispensed, and MOH following Nurtec ODT
initiation.
- Phase 1 results with zavegepant: A Phase 1 study to
evaluate the safety, tolerability and pharmacokinetics of
intranasal zavegepant in single and multiple ascending doses showed
that single and multiple daily doses of intranasal zavegepant of up
to 40 mg were well tolerated. Doses ≥10 mg produced exposures
predictive of efficacy in adults with migraine.
- Non-neurologist migraine management preferences: Results
from a cross-sectional survey described the prevailing opinions of
non-neurologists regarding migraine management based on their
clinical experience and exposure to scientific data. The survey
found that non-neurologists value simplicity and flexibility in
managing migraine, which they perceive as relatively uncommon and
complex. Improving knowledge and education in non-neurology
settings may improve population outcomes among patients with
migraine.
- Migraine prevention treatments: A systematic literature
review and network meta-analysis that evaluated the relative
efficacy of rimegepant, atogepant, and monoclonal antibody (mAb)
treatments for the prevention of migraine. Results showed that all
were effective treatment options for the prevention of migraine
when compared vs placebo and generally showed similar effects when
compared to one another.
- Healthcare Practitioner Satisfaction: A quantitative
survey of people with migraine found that patient satisfaction with
their Healthcare Practitioner (HCP) was related to HCPs actively
listening and asking open-ended questions. Almost all "very
satisfied" participants agreed that their HCPs offered ample time
to discuss their needs during the appointment (98%) and clearly and
thoroughly answered their questions (95%).
The complete list of accepted abstract titles is below. Full
abstracts can be viewed online:
https://index.mirasmart.com/aan2022/.
Oral Presentations:
- Safety, Tolerability, and Pharmacokinetics of Single and
Multiple Ascending Doses of Intranasal Zavegepant in Healthy Adults
(#1003)
- Reduction in Opioid Prescription Fills and Morphine Milligram
Equivalent Dispensed Following Initiation of Nurtec ODT Treatment –
A Real World Administrative Claims Study (#3807)
Poster Presentations:
- Rimegepant Versus Atogepant and Monoclonal Antibody Treatments
for the Prevention of Migraine: A Systematic Literature Review and
Network Meta-analysis (#2972)
- Low Levels of Rimegepant in Breast Milk After a Single 75-mg
Dose (#658)
- An Open-label, Intermediate-sized, Expanded Access Protocol of
Rimegepant in the Acute Treatment of Migraine (#874)
- Acute Treatment with Oral Rimegepant 75 mg Reduces
Migraine-reduced Disability in Adults With and Without a History of
Triptan Treatment Failure: Results from a One-year, Open-label
Safety Study (#873)
- Effect of Strong P-gp and BCRP inhibition, Using Cyclosporin
and Quinidine as Probes, on the Pharmacokinetics of Oral Rimegepant
75 mg in Healthy Subjects (#877)
- Reduction in Period Prevalence of Medication Overuse Headache
following Initiation of Nurtec ODT Treatment – A Real World
Administrative Claims Study (#3698)
- MSQ Utility Mapping of Rimegepant by Change in Monthly Migraine
Days for Preventive Treatment of Migraine (#2972)
- Perspectives from Members of an Online Community on their
Communications with Health Care Professionals about Migraine
Treatment: A Social Listening Analysis (#725)
- Patient Satisfaction is Associated with Positive Communications
with Health Care Professionals: Interim Results from a Survey of an
Online Migraine Community (#998)
- Non-Neurologist Perspectives on Migraine: Results of a
Cross-Sectional Survey (#1344)
- Characterizing the Natural History of Progression in Patients
with Multiple System Atrophy (#350)
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. For more information
about NURTEC ODT, visit www.nurtec.com.
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, 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.
See 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). This is the second
zavegepant pivotal clinical trial to meet these coprimary
endpoints. For more information,
visit www.biohavenpharma.com.
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 five distinct mechanistic platforms: calcitonin
gene related peptide (CGRP) receptor antagonism; glutamate
modulation; myeloperoxidase (MPO) inhibition, Kv7 Ion Channel
Activators (Kv7), and Myostatin. 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.
These forward-looking statements involve substantial risks and
uncertainties, including statements regarding the safety and
efficacy of Nurtec ODT or zavegepant. 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, 2021,
filed with the Securities and Exchange Commission on February 25, 2022, and 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
Jennifer Porcelli
Vice-President, Investor Relations
jennifer.porcelli@biohavenpharma.com
201-248-0741
Media Contact
Mike
Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502
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