Déjà vu: The New Cutting Edge Treatment of Migraines

It’s rimegepant again!

As featured in such posts as … yesterday’s … it’s the same calcitonin gene-related peptide receptor antagonist, but in an entirely separate large, multi-center, double-blind, randomized controlled trial.

And, the results are essentially the same. In this trial, 1,466 participants were randomly assigned to rimegepant or placebo for treatment of a single migraine headache of moderate-to-severe intensity. At two hours post-dose, response rates were 21% with rimegepant and 11% with placebo. Adverse events were similarly rare and generally mild.

Yet again, this tells us rimegepant is better than nothing – and in no way informs us regarding efficacy in their hypothetical patient population: those without response to either over-the-counter therapy or non-responsive/intolerant of the triptans.

Yet again, this study is completely funded by Biohaven Pharmaceuticals, with all the authors employed by and owning stock.

So, the same critiques as yesterday apply – and it’s transparently just another page out of the typical pharmaceutical corporation playbook: do enough to obtain approval, and then let the marketing operation kick into high gear.

“Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial”
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)31606-X/fulltext

Addendum: The protocol does have a non-redacted tidbit of a comparison between rimegepant and sumitriptan, based off some unpublished data from a Phase 2b trial. To be taken with a grain of salt, to be sure, but obviously this would not have looked good for rimegepant if any sort of active comparator would have been used: