Biohaven Presentation at AAN Showed Decreased Opioid Use in Migraine Patients Following Nurtec® ODT Therapy: A Real-World Administrative Claims Analysis

• Longitudinal medical and prescription claims were used to assess opioid prescriptions and MME's dispensed amongst migraine patients nine months prior to and nine months following Nurtec® ODT initiation.  
• Among the 14,019 with migraine who used opioids prior to initiating treatment with Nurtec ODT, approximately 41% had no opioid Rx fills in the 9 months following initiation.  
• Results demonstrate a clinically meaningful reduction in opioid use in this patient population and may be of benefit to those reliant on opioids to manage their disease, thereby alleviating potential negative consequences of opioid use.

NEW HAVEN, Conn., April 7, 2022 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced the presentation of important findings pertaining to the benefit of Nurtec® ODT (rimegepant) in decreasing the burden of opioid use among a significant number of migraine patients in real world clinical practice. These findings were presented as a podium presentation at the American Association of Neurology 2022 Annual Meeting in Seattle, Washington.

The study population was derived from a longitudinal and anonymized integrated commercial medical and prescription claims database. The data contains patient-level claims with plan, payer, facility, procedure, medication, and diagnosis information. To be included in the study patients had to have 18 months of observation data, at least one opioid fill in the baseline period, and at least two Nurtec ODT fills during the follow-up period. The study period was from June 2019 through July 2021. A sub-cohort analysis of current and past/or non-triptan users was also conducted to describe comedication use.

Results for the combined analysis (n=14,019) are described in Figure 1 below. The overall opioid discontinuation rate after Nurtec ODT initiation was 40.5%; results were similar for both triptan sub-cohorts (history of non/past triptan use (39.7%, n=6,580), with current triptan use (41.3%, n=7,439)). Overall, mean monthly opioid Rx fills decreased by 16.1 % (P<.0001), and MMEs were reduced by 2.8% (P<.0001). In the sub-cohort analysis (not shown) a trend of decreasing use was observed in both; refills decreased by 15.3% and 16.8% (both p<.0001) among triptan non/past and current use patients, respectively.

Lead author and presenter, Noah Rosen, M.D., Northwell Physician Partners, Neuroscience Institute of Great Neck, NY commented, "The acute treatment of migraine is an evolving landscape with more specific, novel treatments available to patients.  This study demonstrated in a real-world manner that when people are given a new effective option for their migraines that there is a meaningful reduction in the population's use of opiates." 

Gil L'Italien Ph.D., Senior Vice President, GHEOR & Epidemiology, Biohaven, and co-author of the study, commented, "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 opioids."

NURTEC ODT 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 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. Please click here for full NURTEC ODT 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 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; glutamate modulation for obsessive-compulsive disorder, and spinocerebellar ataxia; and MPO inhibition for amyotrophic lateral sclerosis; Kv7 Ion Channel Activators (Kv7), and Myostatin.  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 regarding the future development, timing and potential marketing approval and commercialization of NURTEC ODT (rimegepant), rimegepant 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 
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201-248-0741

Media Contact
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.