According to Impel NeuroPharma, the FDA has approved the company’s Trudhesa dihydroergotamine mesylate nasal spray for the treatment of migraine. Impel submitted the NDA for Trudhesa (INP104) in November 2020, and the agency accepted the application in January 2021.
The company said that it plans to launch Trudhesa in the US in early October 2021 and that it will offer a “Trudhesa Direct” service that will allow patients who get an electronic prescription to have the nasal spray shipped to directly their homes.
Impel CEO and Chairman Adrian Adams commented, “We are delighted with the approval of Trudhesa and are proud to offer the millions of Americans with migraine a non-oral, acute treatment option that may provide rapid, sustained, and consistent relief, even when taken late into a migraine attack. The approval of Trudhesa marks the culmination of more than a decade of research and advanced engineering to pair the proven efficacy of DHE with our innovative POD technology. We are grateful for all the patients and investigators who participated in our clinical trials and who were instrumental in bringing this needed advancement to the migraine community.”
In addition to Trudhesa, Impel is developing intranasal formulations of olanzapine for the treatment of acute agitation and levodopa for the treatment of OFF episodes in Parkinson’s disease for delivery via the POD device.
Read the Impel press release.
