Biohaven’s Positive Phase 3 Trial Of Rimegepant Zydis® Orally Dissolving Tablet For Acute Treatment Of Migraine Published In The Lancet

Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announces that The Lancet published online positive results from a Phase 3 pivotal clinical trial of rimegepant Zydis® orally dissolving tablet (ODT) for the acute treatment of migraine. These data show that compared to placebo, patients treated with a single dose of the rimegepant ODT formulation experienced rapid and sustained clinical benefits.

“The results from this pivotal Phase 3 study show the significant clinical benefits of freedom from pain and of the most-bothersome migraine-associated symptom within two hours after a single dose of the rimegepant ODT,” said Richard B. Lipton, M.D., Senior Author, Professor and Vice Chair of Neurology at the Albert Einstein College of Medicine and Montefiore Health System, Director of the Montefiore Headache Center. “Migraine has a significant impact on patients’ lives, with more than 90 percent being unable to work or function while they are experiencing a migraine. We found that rimegepant ODT could be an effective new option for those who don’t respond to current available treatments.” Dr. Lipton is also a paid consultant and shareholder of Biohaven.

In this pivotal Phase 3 double-blind, randomized, placebo-controlled trial of rimegepant ODT, 1,375 patients were randomized and treated and 1,351 were evaluated for efficacy (rimegepant n=669, placebo n=682). The trial included endpoints to define the time course of the therapeutic actions of the rimegepant ODT. The use of endpoints earlier than two hours had not been previously investigated.  Rimegepant was shown to be superior on 21 prespecified endpoints with statistical significance demonstrated on the co-primary endpoints of pain freedom and freedom from the most bothersome symptom at two hours post-dose, as well as numerous secondary endpoints defining early and sustained benefits.

Key findings from the study include rimegepant ODT’s significant superiority to placebo on the co-primary endpoints at two hours post-dose for pain freedom (21.2% vs. 10.9%, p<0.0001) and freedom from the most bothersome symptom (35.1% vs. 26.8%, p=0.0009). Rimegepant ODT was superior to placebo on 19 secondary endpoints (p<0.05), including pain relief at 60 minutes (36.8% vs. 31.2%), ability to function normally at 60 minutes post-dose (22.3% vs. 15.8%), pain freedom at 90 minutes (15.1% vs. 7.3%) and freedom from the most bothersome symptom at 90 minutes (27.4% vs. 21.5%), no rescue medication use within 24 hours (85.8% vs. 70.8%), and sustained pain freedom from two to 48 hours (13.5% vs. 5.4%) and pain relief from two through 48 hours post-dose (42.2% vs. 25.2%).

“We are thrilled with the publication of these Phase 3 trial results of rimegepant ODT in The Lancet, an international and influential scientific journal, just days after our oral tablet Phase 3 study was published in The New England Journal of Medicine. These data show rimegepant ODT is a differentiated formulation by demonstrating the time course of effect with early and sustained efficacy and placebo-level tolerability,” said Vlad Coric, M.D., Chief Executive Officer of Biohaven. “Research confirms that up to one-third of patients are dissatisfied with their current acute treatment of migraine. These results show that rimegepant ODT has the potential to meet patients’ needs by providing faster and sustained relief in a convenient form of administration.”

This is the third pivotal Phase 3 clinical trial of rimegepant for the acute treatment of migraine. Results from the first two clinical trials of rimegepant oral tablet have previously been published (study 302 in The New England Journal of Medicine) or presented at scientific meetings. The results of all 3 trials show significant consistency in meeting the co-primary endpoints of pain freedom and freedom from most-bothersome symptoms at 2 hours. The trials were also consistent in showing meaningful gains over placebo in both pain relief and freedom from functional disability at two hours post-dose. Results from the rimegepant oral tablet Phase 3 trials also showed increasing benefit in relief from migraine-associated symptoms after dosing, with a greater proportion of rimegepant patients achieving freedom from photophobia (light sensitivity), phonophobia (sound sensitivity) and nausea over eight hours as compared to placebo. Across the three trials, rimegepant was generally well tolerated, with the most frequent adverse event, nausea, occurring in 1.5% of rimegepant patients, as compared to 0.8% of patients on placebo. Additionally, rimegepant demonstrated a liver safety profile similar to placebo. – PR Newswire