FDA Gives Nod To Nasal Spray Migraine Treatment From Impel NeuroPharma; Stock Jumps

The FDA has approved Impel NeuroPharma Inc's 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.