According to Impel NeuroPharma, the FDA has given the company a notice to proceed with clinical study of INP101 intranasal dihydroergotamine (DHE) for the treatment of acute migraine. A Phase 3 study is expected to begin enrolling patients in the second half of this year.
The company said that it had recently submitted an investigational new drug application to the FDA. In February 2018, Impel said that a Phase 1 study found that INP-104 was well tolerated, had comparable bioavailability to IV DHE and had faster absorption rates than Migranal DHE nasal spray.
Impel NeuroPharma CEO Jon Congleton commented, “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. 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.”
Read the Impel NeuroPharma press release.
