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IHC 2021 | Onset of migraine preventive effects with rimegepant in a Phase II/III trial

Rimegepant is an orally administered CGRP receptor antagonist approved in the United States for the acute treatment of migraine with or without aura and the preventive treatment of episodic migraine in adults, making it the first approved medication for both the preventive and acute treatment setting. Christopher Jensen, PharmD, MBA, Biohaven Pharmaceuticals, New Haven, CT, discusses a post-hoc analysis of the Phase II/III, randomized, double-blind, placebo-controlled trial (NCT03732638) that evaluated the safety and efficacy of rimegepant as a preventive treatment for migraine in adults. The analysis assessed the onset of migraine preventive treatment efficacy with rimegepant during the first four weeks of treatment with an every other day dosing regimen. Findings demonstrated that the CGRP receptor antagonist has migraine preventive effects within the first week of treatment. This interview took place during the International Headache Congress 2021.

Transcript (edited for clarity)

So rimegepant is a small molecule orally-administered CGRP receptor antagonist, and it’s approved in the United States for the acute treatment of migraine with or without aura in adults. And it’s also approved for the preventive treatment of episodic migraine in adults, and it’s the first medication to be approved for both the acute and preventive treatment of migraine. And this Phase II/III clinical trial was a pivotal clinical trial that supported the preventive treatment of migraine approval...

So rimegepant is a small molecule orally-administered CGRP receptor antagonist, and it’s approved in the United States for the acute treatment of migraine with or without aura in adults. And it’s also approved for the preventive treatment of episodic migraine in adults, and it’s the first medication to be approved for both the acute and preventive treatment of migraine. And this Phase II/III clinical trial was a pivotal clinical trial that supported the preventive treatment of migraine approval.

It was a 12-week double-blind placebo-controlled randomized multi-center clinical trial in which patients were randomized one-to-one to either rimegepant 75 milligrams every other day, or placebo every other day, and were treated for 12 weeks. This particular analysis that we presented at IHC looked at the onset of rimegepant preventive treatment effects, and looking specifically at the first four weeks of treatment and seeing how early rimegepant demonstrated a preventive treatment effect.

The main findings of this analysis demonstrated that rimegepant actually has a preventive treatment effect within the very first week of every other day dosing. So what we did was we looked at the weekly migraine day frequency within the first four weeks of the double-blind treatment period in each of those four weeks. And then we compared that to the weekly migraine frequency in the baseline period. And we saw significant reductions in weekly migraine days during some of those weeks, including the very first week of treatment, in which there was a 30% reduction in weekly migraine days for patients treated with rimegepant 75 milligrams every other day, compared to about a 9% reduction in weekly migraine days for the placebo group in that first week.

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Disclosures

Dr Jensen is employed by and holds stock/stock options in Biohaven Pharmaceuticals