Phase III “STOP 301” study of INP 104 shows benefit in migraine.- Impel NeuroPharma

Impel NeuroPharma announced that it has presented patient-reported outcomes data from the Company’s pivotal Phase III, open-label study “STOP 301” of INP 104 (dihydroergotamine mesylate) or DHE using the company’s proprietary POD technology, for the treatment of acute migraine. In the trial, 360 adult patients with migraine were enrolled in a 28-day screening period, during which they received “best usual care.” Over a period of 24 weeks, patients were permitted to self-administer up to three doses of INP104 nasally per week (1.45 mg). Among participants, there were 4,515 reported migraines. Within two hours of receiving their first dose of INP 104, 38% of all patients reported freedom from migraine pain, 52% had freedom from their most bothersome migraine symptom (MBS) and 66.3% experienced pain relief. About 84% of patients reported INP104 easy to use and preferred it over their current therapy. Additionally, sustained pain freedom through 24 hours was also reported in the majority of patients with 98.4% of patients remaining relapse-free of their migraine after using INP104 for 24 weeks. The most common treatment-emergent adverse events (TEAEs) were nasal congestion (15.0%), nausea (6.8%), nasal discomfort and unpleasant taste (5.1% each) with all other TEAEs being reported by less than 3% of participants. There were no treatment related Serious AEs, cardiac TEAEs or deaths. Data were presented in an oral presentation at the Migraine Trust Virtual Symposium (MTIS) to be held from October 3-9, 2020.