Pulmatrix, Inc. (NASDAQ: PULM), a US-based clinical-stage biopharmaceutical company, announced on Tuesday that its PUR3100 investigational new drug (IND) application has been accepted by the US Food and Drug Administration (FDA).

The firm has also received a 'study may proceed' letter for a Phase two, multicentre, randomised, double-blind, placebo-controlled, single event study to evaluate the safety, tolerability, and efficacy of PUR3100 (Dihydroergotamine Mesylate Inhalation Powder) 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.

Dr Margaret Wasilewski, Pulmatrix chief medical officer, said, 'We are pleased with the PUR3100 IND acceptance and receipt of the study may proceed letter for the Phase 2, proof of concept study. We are looking forward to building on the positive safety and pharmacokinetic data established in our phase 1 study.'