- Results from this study demonstrate a robust and clinically
meaningful reduction in barbiturate use after the initiation of
Nurtec ODT, providing an alternative migraine therapy for those who
may be reliant on butalbital or desire an alternative therapy that
is not associated with addiction potential.
- Despite being associated with addiction potential, medication
overuse (rebound) headaches and central nervous system side
effects, barbiturates are prescribed as first-line migraine
treatments.
- Longitudinal medical and prescription claims were used to
assess barbiturate prescriptions and mean milligrams dispensed
amongst migraine patients observed 6 months prior to and following
Nurtec ODT initiation.
- Among the 24,359 with migraine who used butalbital prior to
initiating treatment with Nurtec ODT, approximately 49% had no
butalbital prescription fills in the 6 months following
initiation.
NEW
HAVEN, Conn., Aug. 31,
2022 /PRNewswire/ -- Biohaven Pharmaceutical Holding
Company Ltd. (NYSE: BHVN) announced the important findings
pertaining to the benefit of Nurtec® ODT
(rimegepant) in decreasing the burden of butalbital use among
migraine patients in real world clinical practice.
Noah Rosen, M.D., Northwell
Physician Partners, Neuroscience Institute of Great Neck, NY commented, "Butalbital
containing compound prescriptions remain high despite longstanding
questions of safety in other conditions, significant potential
side effects, multiple drug interactions and risk of dependency and
misuse." Neurologist, Katherine
Standley D.O., Medical Director, Biohaven, commented
"Butalbital has a high risk of leading to medication overuse
headaches, and has led to the American Academy of Neurology (AAN)
and the American Headache Society (AHS) to recommend avoiding its
use as a first line agent in the treatment of headaches."
The study population was derived from a longitudinal and
anonymized integrated commercial medical and prescription
claims database from September 15,
2019 through April 30,
2022. The data contains patient-level claims with plan,
payer, facility, procedure, medication, and diagnosis information.
The observation period for each patient was +/- 180 days from index
fill. To be included in the study, the patient had to have filled
at least 2 Nurtec ODT prescriptions, have at least one butalbital
fill during the baseline observation period, and have sufficient
time in data for baseline and follow-up observation. Barbiturate
formulations studied included butalbital/acetaminophen,
butalbital/acetaminophen/caffeine, and butalbital/aspirin/caffeine.
Barbiturate formulations containing codeine were excluded.
Among 491,149 Nurtec patients, 24,359 met the inclusion criteria
and are described in Figure 1 below. The overall butalbital
discontinuation rate after Nurtec ODT initiation was 48.7%.
Overall, mean monthly butalbital prescription fills decreased by
31.9% and mean milligrams dispensed reduced by 26.2%.
Gil L'Italien Ph.D., Senior Vice President, GHEOR &
Epidemiology, Biohaven, commented, "Despite treatment guidelines
suggesting that barbiturates should be avoided for treatment of
migraine as the first line due to addiction potential, central
nervous system effects and medication overuse headaches,
barbiturate is prescribed in clinical practice, sometimes as first
line in patients who are not candidates for triptans.
Administrative claims provide a rich source of data
on treatment patterns associated with the introduction of
novel medications, and the duration of follow-up affords the
opportunity to assess trends associated with these transitions. Our
findings support the benefit of Nurtec ODT as an effective and safe
migraine treatment that can reduce the need for barbiturates."
Dr. Rosen further commented, "This study has given a real-world
insight into the impact that offering a more specific treatment can
have on driving medication use away from older nonspecific
remedies. Furthermore, by initiating Nurtec ODT, not only did
patients lower butalbital use, but also reduced concurrent
caffeine, acetaminophen or aspirin use due to their presence
in these combination analgesics."
Dr. Standley added, "Prior to the institution of CGRP
antagonists, like Nurtec ODT, we had limited options for acute
management of migraine in patients who were intolerant or not
candidates for triptan therapies. Medications such as opioids and
barbiturate containing analgesics are associated with addiction
potential and increased risk of chronic migraine. This data
supports that Nurtec ODT initiation is associated with a meaningful
reduction in butalbital use in real-world data. When coupled with
the previously presented opioid data, this suggests an overall
reduction in the use of controlled substances with the initiation
of Nurtec ODT."
NURTEC ODT (rimegepant) was approved by the U.S. Food
and Drug Administration (FDA) for the acute treatment of migraine
in February 2020 and for the
preventive treatment of episodic migraine in May 2021.
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.
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,
- are 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 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 treatments
as more than 90 percent of people with migraine are unable to work
or function normally during an attack.
CGRP Receptor Antagonism
Small molecule CGRP receptor
antagonists represent a novel class of drugs for the treatment of
migraine. CGRP receptor antagonists work by reversibly blocking
CGRP receptors, thereby inhibiting the biologic activity of the
CGRP neuropeptide. For acute treatment, this unique mode of action
potentially offers an alternative to other 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. CGRP
signal-blocking therapies have not been associated with medication
overuse headache (MOH) or rebound headaches which limits the
clinical utility of other acute treatments due to increases in
migraine attacks that result from frequent use.
About Biohaven
Biohaven is a global 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
EMA-approved as Vydura® for the acute treatment of migraine
with or without aura, and prophylaxis of episodic migraine in
adults who have at least four migraine attacks per month) and a
broad pipeline of late-stage product candidates across five
distinct mechanistic platforms: CGRP receptor antagonism for the
acute and preventive treatment of migraine; glutamate modulation
for obsessive-compulsive disorder and spinocerebellar ataxia; and
MPO inhibition for amyotrophic lateral sclerosis; Kv7 Ion Channel
Activators (Kv7) activators for focal epilepsy and neuronal
hyperexcitability, and myostatin inhibition for neuromuscular
diseases. More information about Biohaven is available at
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.
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 filed with the Securities and Exchange Commission on
February 25, 2022, and in Biohaven's subsequent
filings with the Securities and Exchange Commission. The
forward-looking statements are made as of the date of this
release, 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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