Biohaven Pharmaceutical Holding Co. Ltd.'s anti-migraine drug rimegepant met the main goals in two late-stage clinical trials.
The medicine was better than placebo at getting rid of pain and "most bothersome" migraine-associated symptoms in patients two hours after taking the first dose, results from the two studies, dubbed BHV3000-301 and BHV3000-302, showed.
In the 301 and 302 trials, 19.2% and 19.6% of migraine patients experienced "pain freedom" two hours after taking the drug, Biohaven said. This compares with 14.2% and 12% of patients in the placebo arm experiencing pain freedom after two hours.
Patients treated with rimegepant also achieved "freedom" from symptoms such as nausea and sensitivity to light or sound two hours after taking the drug — 36.6% and 37.6% versus the placebo group's 27.2% and 25.2%.
Rimegepant was found to be safe and well-tolerated in both the trials, with a safety profile similar to placebo.
"The topline data from our two pivotal trials show that a single, oral dose of rimegepant has the potential to be an effective and safe acute treatment for migraine, addressing both pain and most bothersome symptoms without the need for repeat dosing or rescue medicines," said lad Coric, CEO of Biohaven.
The co-primary goals achieved in the phase 3 trials are in line with the guidance from the U.S. Food and Drug Administration and based on them, Biohaven plans to file for a new drug application in 2019, the New Haven, Conn.-based biopharmaceutical company said.
Migraines are neurological disorders that can cause throbbing, sometime debilitating, headaches.
Rimegepant is part of a licensing deal between Biohaven and Bristol-Myers Squibb Co. It belongs to a class of drugs known as calcitonin gene-related peptide, receptor antagonists that block a small protein found in high levels in the sensory nerves of the head and neck during migraine attacks.
Morgan Stanley's Matthew Harrison in a May 30, 2017, note had projected $150 million in sales in 2020, expecting its launch that year, and $1.4 billion peak sales by 2030 — which would make rimegepant a blockbuster.