Impel NeuroPharma has announced that the Phase 3 STOP 301 study of INP104 intranasal dihydroergotamine mesylate (DHE) for the treatment of acute migraine met its primary objectives, with 66.3% of patients experiencing pain relief and 38% experiencing freedom from pain two hours post dose. Pain relief began as early as 15 minutes post dose for 16.3% of patients using INP104, and no drug-related serious adverse events occurred. The company says that it plans to submit an NDA for INP104 in the second half of 2020.
The STOP 301 study enrolled 360 migraine patients who self administered a 1.45 mg dose of INP104 delivered via the Impel POD device for more than 5,650 migraine attacks. During the initial 24-week treatment period, 26% of patients withdrew from the study. A 28-week extension included 73 patients, 90% of whom completed the study.
Impel NeuroPharma Chief Medical Officer Stephen B. Shrewsbury commented, “We believe that these data add to the growing body of clinical evidence supporting the potential of INP104 to be a transformative new therapy for acute migraine. In addition to the STOP 301 study demonstrating INP104’s potential to be both safe and well-tolerated when delivered to the upper nasal space, the data showed unsurpassed and sustained patient-reported pain freedom and pain relief rates compared to the best usual care in our exploratory efficacy analyses. We believe the low incidence and mild nature of treatment-related adverse events are attributable to INP104’s ability to reliably and consistently deliver an optimal low dose of DHE, which may enable patients to benefit from the established efficacy of this trusted molecule, without undesired side effects that may be experienced with higher doses of drug.”
Read the Impel NeuroPharma press release.
