Zosano announces successful results of pivotal ZOTRIP trial for M 207 (zolmitriptan-coated microneedle patch) as a treatment for migraine.

Zosano Pharma Corporation announces that its lead product candidate, M 207 (zolmitriptan-coated microneedle patch), achieved both co-primary endpoints of pain freedom and most bothersome symptom freedom at 2 hours in the recently completed ZOTRIP trial . The ZOTRIP pivotal efficacy study was a multicenter, double-blind, randomized, placebo-controlled, dose-ranging trial comparing three doses (1.0mg, 1.9mg and 3.8mg) of M207, a novel transdermal therapeutic, to placebo for a single migraine attack.The 3.8mg dose achieved significance in the secondary endpoints of pain freedom at 45 minutes and 1 hour and showed durability of effect on pain freedom at 24 and 48 hours.Overall, higher pain freedom rates were achieved on all doses after 60 minutes over placebo. While the 1.0mg and 1.9mg doses of M 207 produced p-values less than 0.05 in pain freedom at two hours, they did not produce a p-value below 0.05 for the co-primary endpoint of freedom from most bothersome symptom at two hours. Additionally, M207 was not associated with any Serious Adverse Events (SAEs).

Comment:The FDA has indicated that a single, positive, pivotal efficacy study, in addition to a safety study, will be sufficient for approval under a 505(b)(2) pathway. The Company intends to conduct the safety study after completion of the Zotrip trial.