Biohaven Pharmaceutical has reported positive topline results from the Phase III BHV3000-303 or Study 303 clinical trial of zydis.
The trial is designed to investigate the efficacy and safety of rimegepant zydis orally dissolving tablet (ODT) compared with placebo for the acute treatment of migraines.
Results demonstrated that Study 303 met its co-primary registrational objectives of pain freedom and suppression of most bothersome symptom (MBS) at two hours using a single dose of rimegepant zydis ODT.
It was also found that patients who received zydis experienced the onset of pain relief with numerical separation from placebo as early as 15 minutes, while this difference was statistically significant at 60 minutes.
Around 85% of the patients treated with the drug did not use any rescue medications during the trial.
The safety and tolerability of rimegepant was reported to be similar to that observed in Studies 301 and 302.
Biohaven Pharmaceutical CEO Vlad Coric said: “Fast-acting and long-lasting pain relief in an easy to use formulation is important to patients.
“Rimegepant provides these characteristics and we believe is the first oral CGRP receptor antagonist to report superiority over placebo on pain relief and return to normal functioning by 60 minutes.
“These results, combined with the previous data from the two prior Phase III trials, reinforce the potential of rimegepant to be an important new and differentiated option for the acute treatment of migraine.”
Study 303 features a double-blind, randomised, outpatient trial setting.
It enrolled 1,375 patients across sites in the US and treated them with a single 75mg dose of rimegepant zydis ODTor a matching placebo.