Pulmatrix, Inc. announced the submission of an investigational new drug ("IND") application to the United States Food and Drug Administration ("FDA") for PUR3100, an orally inhaled dry powder formulation of dihydroergotamine ("DHE"), under development to treat acute migraine. The PUR3100 formulation uses Pulmatrix's novel, proprietary dry powder delivery technology, iSPERSE(TM) to deliver DHE directly into the lungs using a dry- powder inhaler. Pulmatrix's IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of PUR3100 will be investigated in patients with acute migraine.

The Phase 1 study data were presented at the American Headache Society 65(th) Annual Meeting in June 2023. Results showed that the pharmacokinetics ("PK") of PUR3100 were similar to the PK of intravenous ("IV") DHE with fewer side effects.