Impel NeuroPharma (NSDQ:IMPL) announced today that the FDA approved its Trudhesa nasal spray for treating migraine in adults.
Seattle-based Impel NeuroPharma plans to launch Trudhesa commercially early next month. The company’s shares took a massive hit, though, dropping -19.3% at $18.65 per share by market close and continuing to slide down -0.8% at $18.50 after hours today.
Trudhesa (dihydroergotamine mesylate), previously known as INP104, treats migraine with or without aura in adults through a 0.725 mg per spray dosage, according to a news release.
Impel’s proprietary Precision Olfactory Delivery (POD) technology combines with Trudhesa to gently deliver dihydroergotamine mesylate (DHE) quickly to the bloodstream through the upper nasal space, bypassing the gut and potential absorption issues to offer rapid, sustained and consistent symptom relief without injection or infusion, even when administered hours after the onset of a migraine attack, the company said.
Impel NeuroPharma’s new drug application for Trudhesa cited results from the Phase 3, open-label pivotal safety study, STOP 301, which it said is the largest longitudinal study ever conducted with DHE using nasal spray delivery, treating more than 5,650 migraine attacks over 24 or 52 weeks.
Trudhesa was well tolerated and provided rapid, sustained and consistent symptom relief with no serious drug-related, treatment-emergent adverse events observed. The study showed that 38% of patients had pain freedom, 66% had pain relief and 52% had freedom from their most bothersome migraine symptom at two hours after their first dose. Among the most frequently reported related mild adverse events were nasal congestion (17.8%), nausea (6.8%), nasal discomfort (6.8%), abnormal olfactory test (6.8%) and vomiting (2.7%).
Pain relief started as early as 15 minutes after dosing for 16% of patients, with 93% of those who were pain-free at two hours remaining pain-free at 24 hours, plus 86% stayed pain-free through two days. Additionally, 84% of patients reported that Trudhesa was easy to use and that they preferred it over their current therapy.
“We are delighted with the approval of Trudhesa and are proud to offer the millions of Americans with migraine a non-oral, acute treatment option that may provide rapid, sustained, and consistent relief, even when taken late into a migraine attack,” Impel NeuroPharma chairman & CEO Adrian Adams said in the release. “The approval of Trudhesa marks the culmination of more than a decade of research and advanced engineering to pair the proven efficacy of DHE with our innovative POD technology. We are grateful for all the patients and investigators who participated in our clinical trials and who were instrumental in bringing this needed advancement to the migraine community.”