FDA Gives Nod To Nasal Spray Migraine Treatment From Impel NeuroPharma; Stock Jumps
- The FDA has approved Impel NeuroPharma Inc's (NASDAQ: IMPL) Trudhesa (dihydroergotamine mesylate) nasal spray for the acute treatment of migraine with or without aura in adults.
- Using Impel's Precision Olfactory Delivery technology, Trudhesa gently delivers dihydroergotamine mesylate to the bloodstream through the vascular-rich upper nasal space.
- The commercial launch of Trudhesa is planned for early October 2021.
- In the STOP 301 study, 38% had pain freedom, 66% had pain relief, and 52% had freedom from their most bothersome migraine symptom two hours after their first dose of Trudhesa.
- In July, Impel NeuroPharma closed a $50 million debt facility with Oxford Finance LLC and Silicon Valley Bank.
- Under the terms of the debt facility, the second tranche of $10 million is available upon the approval of Trudhesa.
- Related content: Benzinga's Full FDA Calendar.
- Price Action: IMPL stock traded higher at 50% at $34.68 during the premarket session on the last check Friday. Trading in IMPL shares was halted earlier.
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