Impel NeuroPharma, a Seattle-based, privately-held biopharmaceutical company focused on therapies for the treatment of central nervous system (CNS) disorders, today announced the first patient has been dosed in the Company’s Phase 3, open-label safety and tolerability study evaluating long-term, intermittent use of INP104 for the treatment of migraine headache. INP104 is a novel dihydroergotamine (DHE) product dosed via Impel’s proprietary Precision Olfactory Delivery, or POD®, intranasal delivery device.
The “STOP-301 Trial” (Safety and Tolerability of POD-DHE) will evaluate the safety and tolerability of long-term, intermittent use of INP104 for 24-week and 52-week data points and will also collect efficacy data of INP104 as assessed by change from baseline in migraine measures during the course of the study. Pending complete review of the clinical study data and as a result of rapid recruitment, the Company expects to be in a position to file a New Drug Application (NDA) for INP104 in the second half of 2019.
