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The pharmaceutical company has submitted a New Drug Application for dihydroergotamine mesylate for fast and lasting whole migraine relief in adults with and without aura.
Impel NeuroPharma recently announced its submission of a New Drug Application (NDA) to the FDA for dihydroergotamine mesylate, or DHE, (INP104) for the acute treatment of migraine headaches in adults with or without aura.
DHE utilizes NeuroPharma’s proprietary and novel delivery system called Precision Olfactory Delivery (POD) technology. It is designed to target the vascular rich upper nasal space in order to maximize consistent absorption of DHE.
Migraine is a common and often debilitating severe head pain affecting an estimated 39 million individuals in the United States; however, the disease is underdiagnosed, and of the 19 million patients with diagnosed migraine, only 4 million have been prescribed medication. The neurological disease is associated with symptoms such as nausea, vomiting, and sensitivity to light and sound.
DHE is designed to deliver a lower dose of the drug compared with FDA-approved and investigational products, according to the news release.
The NDA is based on the phase 3, multicenter STOP 301 study. The study included 360 patients at 36 trial sites in the US. Patients were included based on their documented diagnosis of migraine with or without aura who experienced a minimum of 2 attacks each month for the last 6 months at the time of the study. Investigators evaluated patients either under a 24-week or 52-week study period.
Study investigators treated over 5650 migraine attacks during the study and met the primary objectives, with no new safety signals reported. The most frequently reported treatment-emergent adverse events (TEAEs) were mild and brief and included nasal congestion (16.7%), nausea (7.9%), nasal discomfort (5.4%), and abnormal taste (5.1%).
Overall, 66.3% of patients reported pain relief, 38% reported pain freedom, and 52% reported freedom from their most bothersome migraine symptom (MBS) within 2 hours of the first dose of DHE. A total of 16.3% of patients experienced relief from their migraine in as early as 15 minutes, with improvements over time.
The STOP 301 study is among the largest longitudinal studies of DHE, according to the news release.