The Food and Drug Administration has approved Trudhesa™ (dihydroergotamine mesylate) nasal spray for the acute treatment of migraine with or without aura in adults.
Trudhesa uses proprietary technology to deliver a lower dose (0.725mg per spray) of dihydroergotamine mesylate to the upper nasal space. The therapeutic activity of dihydroergotamine in migraine is generally attributed to the agonist effects at 5-HT1D receptors.
The approval is supported by data from the open-label phase 3 STOP 301 study (ClinicalTrials.gov Identifier: NCT03557333), which evaluated the safety and tolerability of Trudhesa in 354 adults who had a documented diagnosis of migraine with or without aura, including at least 2 attacks per month for the previous 6 months. Patients who received at least 1 dose of Trudhesa comprised the full safety set (n=354), and patients who took at least 2 doses of Trudhesa per 28-day period during the 24-week treatment period comprised the primary safety set (n=185). The primary safety endpoints included serious and non-serious treatment emergent adverse events as well as changes in nasal mucosa and olfactory function.
Results showed that the study met its primary endpoints with no new safety signals. Additional exploratory efficacy data in the full safety set showed that after the first dose, 66.3% of patients achieved pain relief, 38% of patients had pain freedom, and 52% had freedom from their most bothersome migraine symptom at 2 hours. Among patients who were pain free at 2 hours, 93% remained pain free at 24 hours, and 86% remained pain free through day 2.
The most common adverse reactions reported with Trudhesa were rhinitis, nausea, altered sense of taste, application site reactions, dizziness, vomiting, somnolence, pharyngitis, and diarrhea.
Trudhesa is supplied as a package of 4 single-dose units with 1 nasal spray device; each unit contains a vial of dihydroergotamine mesylate 4mg. Each spray delivers 0.725mg of dihydroergotamine mesylate; the recommended dose is 1.45mg administered as 2 metered sprays into the nose (1 spray of 0.725mg into each nostril).
Trudhesa is expected to be available in early October 2021. The Company is providing a copay savings program for eligible patients.
- Impel NeuroPharma announces US FDA approval of Trudhesa™ (dihydroergotamine mesylate) nasal spray for the acute treatment of migraine. News release. Impel NeuroPharma. September 3, 2021. Accessed September 7, 2021. https://www.globenewswire.com/news-release/2021/09/03/2291459/0/en/Impel-NeuroPharma-Announces-U-S-FDA-Approval-of-TRUDHESA-Dihydroergotamine-Mesylate-Nasal-Spray-for-the-Acute-Treatment-of-Migraine.html.
- Trudhesa. Package insert. Impel NeuroPharma; 2021. Accessed September 7, 2021. https://www.trudhesa.com/trudhesa-prescribing-information.pdf.