The Food and Drug Administration has approved Trudhesa ™ (dihydroergotamine mesylate) nasal spray for the acute treatment of migraines with or without aura in adults.
Trudhesa uses proprietary technology to deliver a lower dose (0.725 mg per spray) of dihydroergotamine mesylate into the upper nasal cavity. The therapeutic activity of dihydroergotamine in migraine is generally attributed to its agonistic activity at 5-HT1D receptors.
The approval is supported by data from the STOP 301 open-label Phase 3 study (ClinicalTrials.gov Identifier: NCT03557333) evaluating the safety and tolerability of Trudhesa in 354 adults with a documented diagnosis of migraine with or without aura, including at least 2 seizures per month in the last 6 months. Patients who received at least 1 dose of Trudhesa included the full safety kit (n = 354) and patients who took at least 2 doses of Trudhesa per 28 days during the 24-week treatment period included the primary safety kit (n = 185). The primary safety endpoints included serious and non-serious treatment-related adverse reactions and changes in nasal mucosa and olfactory function.
The results showed that the study met its primary endpoints with no new safety signals. Additional exploratory efficacy data from the full safety set showed that 66.3% of patients achieved pain relief after the first dose, 38% of patients were pain-free, and 52% were clear of their most troublesome migraine symptom after 2 hours. Of the patients who were pain-free after 2 hours, 93% remained pain-free after 24 hours and 86% remained pain-free by the second day.
The most commonly reported adverse reactions with Trudhesa were rhinitis, nausea, altered sense of taste, application site reactions, dizziness, vomiting, drowsiness, pharyngitis, and diarrhea.
Trudhesa is supplied as a pack of 4 single dose units with 1 nasal spray; each unit contains one vial of dihydroergotamine mesylate 4 mg. Each puff provides 0.725 mg of dihydroergotamine mesylate; the recommended dose is 1.45 mg given as 2 metered sprays into the nose (1 puff of 0.725 mg in each nostril).
Trudhesa is expected to be available in early October 2021. The company offers eligible patients a copay savings program.
- Impel NeuroPharma announces US FDA approval for Trudhesa ™ (dihydroergotamine mesylate) nasal spray for the acute treatment of migraines. Press 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-US-FDA-Approval- of -TRUDHESA-dihydroergotamine-mesylate-nasal-spray-for-the-acute-treatment-of-migraine.html.
- Trudhasa. Package insert. Impel NeuroPharma; 2021. Accessed September 7, 2021. https://www.trudhesa.com/trudhesa-prescribing-information.pdf.
This article originally appeared on MPR
Migraines migraines and headache pain management