Biohaven Pharmaceutical Holding Company Ltd. said two different dose strengths of its intranasal experimental therapy for migraine, called vazegepant, were better than placebo in freeing patients from pain and other symptoms after two hours of receiving the treatment during a late-stage study.
The New Haven, Conn.-based biotech, which develops treatments for neurological diseases, was comparing the single doses of 5 milligrams, 10 milligrams and 20 milligrams of intranasal vazegepant with placebo in migraine patients during the phase 2/3 trial.
Results showed that the 10-milligram and 20-milligram groups were statistically significant compared to placebo in ensuring freedom from pain and most bothersome symptom, or MBS, the main goals of the trial, according to Biohaven's Dec. 17 press release.
MBS is specified by the patient as the most annoying symptom of migraine other than pain that can either be a discomfort experienced due to exposure to light or loud sounds, or nausea.
Additionally, the 10 milligrams and 20 milligrams of the intranasal drug started pain relief 15 minutes after the treatment, while patients receiving the higher strength dose returned to normal function as early as 30 minutes.
The U.S. Food and Drug Administration accepted for review Biohaven's application for its lead product and migraine therapy Zydis, or rimegepant, in September and expects to make a decision in the first fiscal quarter of 2020.