Pulmatrix announced the FDA has accepted the PUR3100 investigational new drug application and the company has received a study may proceed letter for a Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single Event Study to Evaluate the Safety, Tolerability, and Efficacy of PUR3100 in the Acute Treatment of Migraine. The PUR3100 formulation uses Pulmatrix’s novel, proprietary dry powder delivery technology, iSPERSE to deliver DHE via oral inhalation using a dry powder inhaler.
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