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Midazolam Nasal Spray (USL261) Phase 3 Trial Meets Primary Efficacy Endpoint In Patients With Seizure Clusters

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CAMBRIDGE, England, April 26, 2017 /PRNewswire/ — Proximagen Limited (Proximagen) today announced that its pivotal Phase 3 trial of intranasal midazolam (USL261) for the rescue treatment of seizure clusters, met its primary efficacy endpoint in a top-level analysis of the data. Based on these findings, Proximagen will approach the U.S. Food and Drug Administration (FDA) regarding its proposal to submit a 505(b)(2) New Drug Application (NDA) in the second half of this year. USL261 has been granted orphan drug designation and fast track designation for this use by the FDA. Findings from the trial will be presented at the upcoming Antiepileptic Drug and Device Trials (AEDD) meeting, May 17-19, 2017 in Adventura, Florida. Read more