Impel NeuroPharma said that the Phase 3 STOP-301 safety and tolerability study of INP104 intranasal dihydroergotamine (DHE) for the treatment of migraine has gotten underway, with the first patient dosed. The company announced plans for the study in June 2018.
According to Impel, recruitment for the study, which will gather data at 24 weeks and 52 weeks of intermittent use of INP104 by migraine patients, has been going well, and the company is planning for submission of an NDA for the product in the second half of 2019.
Impel NeuroPharma CEO Jon Congleton commented, “We are very pleased with the speed of recruitment to the STOP-301 study and anticipate that this reflects the level of unmet need in the market and enthusiasm for novel treatments. We believe that INP104 stands to provide a gold-standard migraine therapy in a device that offers rapid and optimized bioavailability.”
Read the Impel NeuroPharma press release.
