Biohaven Preps to Submit Expanded Label for Nurtec Following Positive Migraine Trial Results

Biohaven Pharma announced positive topline data from its Phase III trial of oral rimegepant (Nurtec) for preventing migraine headaches in both episodic and chronic migraine patients. The primary endpoint was a statistically significant decrease from baseline in monthly migraine days compared to placebo.

“Rimegepant is the first CGRP targeting therapy to complete pivotal trials that demonstrate efficacy in both the acute and preventive treatment of migraine,” said Vlad Coric, Biohaven’s chief executive officer. “The magnitude of effect in the rimegepant treated arm of a 4.5 day reduction at three months in this study was on the higher end of what has been demonstrated by other approved preventive drugs for migraine patients with similar baseline. We believe rimegepant has the potential to change the paradigm of migraine treatment, offering patients the potential for dual-therapy action—acute and preventive treatment—in one simple dose and convenient formulation.”

The clinical pivotal trial enrolled patients that had both episodic and chronic migraine. It evaluated the efficacy and safety of the drug at a 75 mg dose every other day for the prevention of migraine compared to placebo. The patients had migraine for at least one year and four to 18 moderate to severe migraine attacks per month over three months before enrollment.

The patients receiving the drug had 4.5 days fewer migraines compared to 3.7 less in the placebo group. In patients not taking concomitant preventive treatment, there was a 4.9-day reduction in monthly migraine days in the rimegepant group compared to 3.7 days in the placebo group. About 22% of patients in the trial were taking other preventive treatments at the time, including topiramate and amitriptyline. Of the rimegepant group, 48% had at least a 50% decrease in the mean number of moderate to severe migraine days per month compared to 41% in the placebo group.

The safety profile in this study was consistent with that seen in previous clinical trials. Oddly, discontinuation rates were higher in the placebo arm. The company indicates this was because a larger number of patients in the placebo arm withdrew consent compared to the 3% rate in the rimegepant group.

Nurtec ODT (rimegepant) is indicated for acute treatment of migraine with or without aura in adults. It is not yet indicated for prevention of migraine, although the results of this trial suggest it might be approved for that in the future.

“These data demonstrate rimegepant’s broad range of clinical activity to potentially provide a new oral preventive treatment option for people with migraine,” said Robert Croop, Biohaven’s chief development officer – Neurology. “The magnitude of effect in the rimegepant treated arm with favorable safety and tolerability suggest that rimegepant could be a best-in-class oral therapy for both preventive and acute treatment of migraine.”

Richard B. Lipton, professor and vice chair of Neurology at the Albert Einstein College of Medicine and Montefiore Health System, and Director of the Montefiore Headache Center, stated, “I see many patients who are discouraged by the limited current preventive treatment options and continue to look for a better way to prevent disabling migraine attacks. This is the first time that patients may be able to use a single drug for both acute and preventive treatment. Particularly impressive is the fact that the primary outcome measure of reduction in monthly migraine days was achieved with every other day dosing.”

The company plans to submit supplementary drug applications to the U.S. Food and Drug Administration and the European Medicines Agency for rimegepant for preventive treatment of migraine.