Positive Results in Phase 3 Trial of Rimegepant for Oral Acute Treatment of Migraine

 

Results from a phase 3 clinical trial show that treatment with rimegepant (Zydis; Biohaven, New Haven, CT) provided significantly more relief from pain and most bothersome symptoms (MBS) compared with treatment with placebo for acute treatment of migraine. Of 669 patients treated with an orally dissolving tablet formulation of 75 mg rimegepant, 21.2% had freedom from pain within 2 hours compared to only 10.9% of those treated with placebo (P = < .0001). In addition, 35.1% of patients treated with rimegepant had relief from their MBS compared with 26.8% of those treated with placebo. Of note, most patients treated with rimegepant (85%) did not need other rescue medications. 

Patients were instructed to take treatment or placebo when they had a headache that reached moderate to severe pain. Treatment with rimegepant had fast-acting effects, beginning as early as 15 minutes after taking a single dose. The proportion of patients taking rimegepant who had significantly more pain relief compared to those treated with placebo was evident as early as 60 minutes after taking the medication (P < .0001). More patients treated with rimegepant returned to normal functioning within 60 minutes (P = .003)

Benefits of treatment were evident through 48 hours, including measures of freedom from pain (P < .0001), pain relief (P < .0001), freedom from the most bothersome symptom (P = .0018), and freedom from functional disability (P <  .0001). Superiority over placebo was also demonstrated in multiple other secondary endpoints. 

Pooled liver function test results across this and 2 other trials of rimegepant (n = 3,556) showed that rimegepant was similar to placebo with regard to elevated liver enzymes, and the rate of adverse events from treatment with rimegepant was similar to placebo.  

Vlad Coric, MD, Chief Executive Officer of Biohaven, stated, "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 3 trials, reinforce the potential of rimegepant to be an important new and differentiated option for the acute treatment of migraine."

 

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