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Zosano Pharma announces completion of enrollment in pivotal efficacy trial for M207 for acute migraine

Published 11/08/2016, 11:35 AM
Zosano Pharma announces completion of enrollment in pivotal efficacy trial for M207 for acute migraine
ZSANQ
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  • Zosano Pharma (NASDAQ:ZSAN) announces completion of enrollment in its registration-enabling, pivotal efficacy trial (the Zotrip trial), of M207 for the treatment of acute migraine.
  • Management: “The completion of enrollment in the Zotrip study is a major milestone for the company and bolsters our confidence in the previously announced availability of trial data in the first quarter of 2017. The enrollment pace is also indicative of the urgent need for improved treatment options for those suffering with acute migraine.”
  • About the Zotrip Trial: The pivotal efficacy trial is a multicenter, double-blind, randomized, placebo-controlled trial comparing three doses of M207 (1.0 mg, 1.9mg, and 3.8mg) to placebo for the treatment of a single migraine attack. Subjects recruited have a history of at least one year of episodic, acute migraines with or without aura.
  • Co-primary endpoints of this study are: 1. Pain freedom at 2 hours post-dosing, and, 2. Freedom from each subject’s most bothersome symptom at 2 hours post-dosing.
  • 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.
  • Source: Press Release

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