FDA Clears the Way for Phase 3 Acute Migraine Headache Trial

The US Food and Drug Administration (FDA) cleared a clinical trial of INP104, a novel dihydroergotamine (DHE) product for the treatment of acute migraine, announced Impel NeuroPharma. The drug is dosed through Impel’s Precision Olfactory Delivery (POD), an intranasal delivery device.

"DHE is an effective, trusted cornerstone treatment for acute migraines, however current methods of administration by injection or traditional nasal spray devices have created barriers to its widespread use," said Jon Congleton, Chief Executive Officer of Impel NeuroPharma in a statement.

Impel received FDA permission to proceed with the phase 3 trial following their submission of an investigational new drug (IND) application for the program. The study will evaluate the safety and tolerability of long-term, but intermittent use of INP104 for the treatment of acute migraine headache.

The Precision Olfactory Deliver device is designed for ease of use and delivers consistent and predictable doses of DHE. POD delivers DHE to the upper nasal cavity, providing rapid bioavailability without the need for injection.

DHE is an established and effective treatment option for acute migraine that has been approved by the FDA since 1946 in its injectable form.

"We believe the consistent, reliable delivery of DHE via Impel's POD intranasal device could provide a promising treatment option for both patients and their healthcare providers, and we look forward to progressing the development of INP104 as a potential acute migraine therapy," said Congleton.

Impel NeuroPharma expects to begin enrolling study participants in the phase 3 trial during the second half of 2018.

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