Biohaven announced positive topline results from a pivotal phase 2/3 study evaluating rimegepant for the preventive treatment of episodic and chronic migraine in adults. Rimegepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, is currently approved under the brand name Nurtec ODT for the acute treatment of migraine in adults with or without aura.
The randomized, double-blind, placebo-controlled study compared the efficacy and safety of rimegepant 75mg every other day (n=348) to placebo (n=347) in patients who had migraine for at least 1 year and 4 to 18 moderate to severe migraine attacks per month over 3 months prior to enrollment. The primary end point was the change from baseline in mean migraine days per month over the 12-week period.
Findings from the study showed that treatment with rimegepant was associated with a statistically significant reduction in monthly migraine days from baseline (-4.5 days vs -3.7 days with placebo; P =.0176). Moreover, a reduction of 4.9 monthly migraine days was observed among patients treated with rimegepant not on concomitant preventive treatment (eg, topiramate and amitriptyline), compared with a 3.7 day reduction in the placebo group (nominal P =.002).
In addition, a greater proportion of rimegepant-treated patients reported a ≥50% reduction from baseline in the mean number of moderate to severe migraine days per month compared with placebo (48% vs 41%).
The safety profile of rimegepant was consistent with that seen in previous studies. The most common treatment-emergent adverse reaction was nausea.
Commenting on the study results, Vlad Coric, MD, Chief Executive Officer of Biohaven, said: “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. 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.”