As per notification published on 14 October 2020, the supplemental New Drug Application (sNDA) for rimegepant (calcitonin gene-related peptide receptor antagonist) has been approved for review by the Food and Drug Administration (FDA) to effectively prevent attacks of migraine.

The goal is to provide a rapid-acting, fast-dissolve oral tablet having dual-acting effects (acute and preventive) to combat migraine across its full spectrum. The ease of use linked with a single oral tablet will profit patients suffering from migraine. It will offer the medical care system a cost-effective way rather than purchasing two separate medications for preventive and acute management.

This sNDA is supported by the data from a randomized, placebo-controlled, phase II/III, double-blind study. This study was conducted to investigate rimegepant's safety and efficacy in individuals who had migraine attacks for at least one year and moderate to severe migraine attacks (4-18) per month over three months before recruitment.

Participants were randomly assigned to the rimegepant group (n=348, 75 mg orally every other day) and the placebo group (n=347). The alteration from baseline in the average migraine days/month over 12-weeks was the primary outcome parameter.

In comparison with patients receiving a placebo, patients receiving rimegepant attained a substantial minimization in monthly migraine days from baseline. Compared to patients treated with placebo, a higher percentage of patients treated with rimegepant witnessed a ≥50% decline from baseline in the average number of moderate to severe migraine days/month, as shown in the following table:

Furthermore, a decline of 4.9 monthly migraine days was noted in patients receiving rimegepant not on concomitant preventive therapeutic (such as amitriptyline and topiramate), in comparison with a 3.7-day decline in the patients receiving placebo.

Rimegepant's safety profile displayed consistency with that noted in the previous studies. Nausea was the most frequent therapy-emergent adverse effect. An open-label long-term safety study that investigated rimegepant's safety and tolerability with multiple doses for up to one year also supported the sNDA.

For the second quarter of the year 2021, a Prescription Drug User Fee Act (PDUFA) target action date for the application has been established. Presently, this drug is approved for acute management of migraine with or without aura and is supplied as 75 mg orally disintegrating tablets in a blister pack of eight.