Biohaven has announced that its FDA-approved migraine treatment, rimegepant (Nurtec ODT), met its primary end point in the preventive treatment of migraine in both episodic and chronic migraine patients.
Patients who received oral rimegepant 75 mg every other day experienced a statistically significant 4.5-day reduction from baseline in monthly migraine days, compared to a 3.7-day reduction in placebo group (P = .0176).
"Rimegepant is the first CGRP targeting therapy to complete pivotal trials that demonstrate efficacy in both the acute and preventive treatment of migraine. The magnitude of effect in the rimegepant treated arm of a 4.5-day reduction at 3 months in this study was on the higher end of what has been demonstrated by other approved preventive drugs for migraine patients with similar baselines,” Vlad Coric, MD, chief executive officer of Biohaven, said in a statement.
In February, the FDA approved the use of 75-mg rimegepant in the acute treatment of migraine in adult patients, marking the company’s first agency approval of a product. A month later, the calcitonin gene-related peptide (CGRP) became available for prescription in pharmacies across the US.
This phase 2/3, double-blind, placebo-controlled study (NCT03732638), randomized patients with episodic and chronic migraine in 1:1 fashion to 75-mg rimegepant (n = 370) or placebo (n = 371). Patients included in the study had migraine for at least 1 year, with 4–18 moderate to severe migraine attacks per month over the 3 months prior to enrollment.
Primary outcome measures of the study included change in baseline in mean number of migraine days per month over a 12-week period. Secondary outcome measures observed were achievement of at least 50% reduction from baseline in mean number of moderate to severe monthly migraine days, mean number of rescue medication days per month and adverse events.
During the 1-month observation period, patients experienced an average of 10.7 migraine days during the 4-week month, with 7.4 migraine days of moderate to severe pain intensity migraine during the same period.
An additional analysis included patients administered 75-mg rimegepant (n = 269) and placebo (n = 273) not taking concomitant preventative treatments. Concomitant preventive treatments such as topiramate and amitriptyline accounted for 22% of the study participants.
Researchers noted a 4.5-day reduction from baseline in monthly migraine days with patients who received 75-mg rimegepant every other day (n = 348), compared to a 3.7-day reduction in the placebo group (n = 347; P = .0176). Additionally, among those not taking concomitant preventive treatments, there was a 4.9- and 3.7-day reduction in monthly migraine days in patients who received 75-mg rimegepant (n = 273) and placebo (n = 269; nominal P = .0020).
Among those who received 75-mg rimegepant, 48% of patients had at least 50% reduction from baseline in the mean number of moderate to severe migraine days per month, compared to 41% in the placebo group.
Treatment with rimegepant was consistent with prior clinical trials. There was a 6% discontinuation rate in placebo group due to withdrawing consent compared to 3% in rimegepant treated participants.
“If successful in expanding our label for NURTEC ODT to include prevention, patients for the first time will have the convenience of one oral medication to treat their migraine across the spectrum instead of having to mix different acute and preventive medications," Coric added in a statement.
Biohaven plans to engage the FDA and European Medicines Agency to submit a subordination non-disturbance and attornment (sNDA) and marketing authorization application (MAA), respectively, for rimegepant for the indication of preventive treatment of migraine.
Biohaven achieves positive results in pivitol trial of oral Nurtec, dosed every other day, for the preventive treatment of migraine [news release]. New Haven, CT: Biohaven; Published March 30, 2020. Accessed March 30, 2020. prnewswire.com/news-releases/biohaven-achieves-positive-results-in-pivotal-trial-of-oral-nurtec-dosed-every-other-day-for-the-preventive-treatment-of-migraine-301031432.html