Zosano Announces new trial results for its Headache drug

Zosano Pharma Corporation, a clinical-stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics to subjects using its proprietary Adhesive Dermally-Applied Microarray (“ADAM™”) technology, announced that Headache, the Journal of Head and Face Pain, has published the post-hoc analysis on the use of most bothersome symptom (MBS) as a co-primary endpoint from the Company’s ZOTRIP pivotal study.

Headache published the paper titled “Use of Most Bothersome Symptom as a Coprimary Endpoint in Migraine Clinical Trials: A Post-Hoc Analysis of the Pivotal ZOTRIP Randomized, Controlled Trial”. The paper analyzes the positive MBS results from Zosano’s ZOTRIP pivotal study, a multi-center, double-blind, placebo-controlled trial demonstrating the efficacy and safety of M207, Zosano’s novel proprietary formulation of zolmitriptan using its ADAM technology.  The ZOTRIP pivotal study, evaluating ADAM zolmitriptan for the acute treatment of migraine, was one of the first large studies to incorporate MBS freedom and pain freedom as co-primary endpoints, per recently issued guidance by the US Food and Drug Administration.  MBS freedom at two hours was observed in 68% of M207 3.8 mg subjects as compared to 43% of placebo subjects (P < .01).

“We are pleased to see this aspect of the ZOTRIP pivotal study published and hope that the results and discussion will be helpful to others designing and interpreting trials of acute treatment of migraine,” said Dr. Don Kellerman, Vice President of Clinical Development.  “Since the time of our manuscript submission, several other trials have reported results using these coprimary endpoints, and we look forward to their publication.”

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News Source: Zosano Pharma

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