Pulmatrix has submitted an investigational new drug (IND) application to the United States Food and Drug Administration (FDA) for PUR3100.

The US-based clinical-stage biopharmaceutical company develops inhaled therapy for pulmonary and central nervous system disease.

PUR3100 is an orally inhaled dihydroergotamine (DHE) formulated as dry powder and used with Pulmatrix’s iSPERSE technology for the treatment of acute migraine.

Pulmatrix completed subject dosing in its Phase I clinical trial in September 2022. The Phase I trial was a randomised, double-dummy, double-blinded design to evaluate the safety, tolerability, and pharmacokinetics of three dose groups of inhaled PUR3100 with IV placebo, compared to a single dose of IV DHE (DHE mesylate injection) with inhaled placebo.

The Phase I study data were presented at the American Headache Society 65th Annual Meeting in June 2023. The pharmacokinetics of PUR3100 were similar to those of intravenous DHE but with fewer side effects.

As part of Pulmatrix’s IND application, the safety and preliminary efficacy of PUR3100 will be investigated in patients with acute migraine.

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Migraine and severe headaches have a high prevalence in the US, with roughly one out of every six people suffering at least once over a three-month period. Historically, treatment has been limited to oral triptan with an NSAID or paracetamol.

Dr Margaret Wasilewski, chief medical officer of Pulmatrix, commented: “Based on study results seen to date, we believe that PUR3100 using Pulmatrix’s iSPERSE technology could offer a DHE therapy with maximised efficacy, while also providing the convenience of self-administration and reduced systemic side effects.”

According to GlobalData, global sales for migraine drugs were valued at $4.6bn in 2020, with a compound annual growth rate of more than 9%. The US dominated the migraine market in 2020, contributing to more than 80% of the sales in the seven major pharmaceutical markets (7MM) covered – the US, 5EU (France, Germany, Italy, Spain, and the UK), and Japan.