Phase III trial results of Zydis for migraine published in New England Journal of Medicine

Zydis (rimegepant), from Biohaven Pharmaceutical, a new generation of acute migraine headache treatment, was found to eliminate pain and reduce bothersome symptoms for people with migraine in a large-scale trial reported in the July 11 issue of The New England Journal of Medicine. Rimegepant is awaiting FDA approval and may offer advantages over currently available migraine medications. The New England Journal of Medicine trial assessed rimegepant, in a phase III randomized double-blind trial involving more than 1,000 men and women with migraine at 49 centers in the U.S.

The participants were instructed to take a tablet of rimegepant, or a matching placebo tablet, during a migraine attack, once moderate or severe pain developed. Before taking the tablet and for 48 hours afterwards, patients answered questions in an electronic diary concerning their pain and their most bothersome symptoms. Participants chose their most bothersome symptom from a list, including intolerance to light, intolerance to loud sounds, or nausea. Two hours after taking their tablets, 19.6% of patients in the rimegepant group were free from pain compared with 12.0% in the placebo group--a statistically significant difference. Freedom from their most bothersome symptoms occurred in 37.6% of patients in the rimegepant group and 25.2% in the placebo group. Side effects were minimal, with nausea and urinary tract infections the only adverse effects reported in more than 1% of patients in each group and no adverse CVD effects observed.

See: "Rimegepant, an Oral Calcitonin Gene–Related Peptide Receptor Antagonist, for Migraine" Richard B. Lipton et al. N Engl J Med 2019; 381:142-149 July 11, 2019 DOI: 10.1056/NEJMoa1811090