M207: Ph II/III Zotrip data

The pivotal, double-blind, U.S. Phase II/III Zotrip trial of transdermal M207 in 565 patients with acute migraine showed that the highest dose of 3.8 mg M207 met the co-primary endpoint of improving the percentage of patients with pain freedom from baseline at 2 hours vs. placebo (41.5% vs. 14.3%, p=0.0001). It also met the co-primary endpoint of increasing patients free of their most bothersome other symptom to 2 hours vs. placebo (68.3% vs. 42.9%, p=0.0009). M207 met secondary endpoints of increasing patients with pain freedom at 45 minutes (17.1% vs. 5.2%, p=0.0175); 60 minutes (26.8% vs. 10.4%, p=0.0084); 24 hours (69.5% vs. 39%, p=0.0001); and 48 hours (64.6% vs. 39%, p=0.0013). Zosano said the 1 and 1.9 mg doses of M207 each met the pain freedom co-primary endpoint, but missed the most bothersome other symptom co-primary endpoint. Zosano did not provide detailed data for the 2 lower doses. M207 was well tolerated with no serious adverse events reported. ...