Rapid relief of migraine pain with orally dissolving rimegepant
A new orally dissolving tablet (ODT) formulation of rimegepant showed rapid onset of action and sustained benefits in terms of pain relief and symptom improvement in patients with acute migraine, the 303 study finds.
Rimegepant ODT doubled the proportion of patients who were free from pain at 2 hours post-treatment compared with the placebo group (21.2 percent vs 10.9 percent; p<0.0001). [AAN 2019, abstract ES.005]
Significantly more patients treated with rimegepant ODT reported being free from the most bothersome symptom 2 hours after dosing compared the placebo group (35.1 percent vs 26.8 percent; p=0.0009).
Rimegepant is an oral CGRP*-receptor antagonist which has previously been proven to be effective in tablet form. The current study is on an ODT formulation with 30 minutes earlier time to maximal concentration (Tmax) than the tablet form.
In the multicentre, double-blind, phase III trial, 1,375 patients (mean age 40 years, 85 percent female) with at least 1-year history of migraine were randomized to a single dose of rimegepant ODT 75 mg or placebo to treat a migraine attack of moderate or severe pain intensity.
The study met both the coprimary endpoints of freedom from pain and the most bothersome symptom 2 hours after dosing as stated above. The patient-reported most bothersome symptom included nausea, phonophobia, and photophobia.
More patients in the rimegepant arm had pain relief compared with the placebo arm at 60 minutes (p=0.0314) and 90 minutes (p<0.0001). Pain relief was sustained up to 48 hours in significantly more patients treated with rimegepant than with placebo (p<0.0001).
Freedom from the most bothersome symptom was also achieved by more patients taking rimegepant than placebo at 90 minutes (p=0.0128), an effect which sustained through to 48 hours (p<0.0018).
Furthermore, more patients in the rimegepant arm were able to return to normal function 48 hours post-dosing (p<0.0001).
The rates of adverse events (AEs) were low, with urinary tract infection and nausea being the most commonly reported AEs at ≤1.6 percent. There were no reports of serious treatment-emergent AEs.
“A single dose of rimegepant ODT achieved its coprimary endpoints and demonstrated rapid and sustained clinical benefits within 60 minutes and through 48 hours post-dose,” the researchers concluded. “These results suggest that rimegepant ODT has a fast onset and placebo-like tolerability in the acute treatment of migraine.”