Impel Neuropharma Presents Data for the 2020 Migraine Trust Virtual Symposium
Product News Oct 09, 2020
Impel NeuroPharma, a biopharmaceutical company focused on the development and commercialization of therapies for patients living with central nervous system (CNS) disorders with high unmet medical needs, announced that it has presented patient-reported outcomes data from the Company’s pivotal Phase 3, open-label study “STOP 301” of INP104 (dihydroergotamine mesylate) or DHE using the company’s proprietary POD technology, for the treatment of acute migraine in an oral presentation at the Migraine Trust Virtual Symposium (MTIS) to be held from October 3-9, 2020.
“Despite several recent approvals, there remains a significant need for acute treatments that provide early and sustained relief, are easy to use and well tolerated,” said Stephen Shrewsbury, M.D., Chief Medical Officer at Impel NeuroPharma. “The response between the safety and efficacy results from STOP-301 combined with the patient-reported tolerability, acceptability and exploratory efficacy results are encouraging and provide further evidence that INP104, the first and only product designed to deliver DHE to the vascular-rich upper nasal space using our proprietary POD technology, may offer a promising treatment option for the acute treatment of 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 INP104, 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.