Real-World Administrative Claims Analysis Demonstrates That Almost Half of Migraine Patients Discontinue Barbiturate Use After Initiation of Nurtec ODT

• 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
[email protected]
201-248-0741

Media Contact
Mike Beyer
Sam Brown Inc.
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312-961-2502

SOURCE Biohaven Pharmaceutical Holding Company Ltd.