The US Food and Drug Administration (FDA) has approved an intranasal formulation of dihydroergotamine mesylate (DHE) for the acute treatment of migraine with or without aura in adults.
Trudhesa (formerly INP104), from Impel NeuroPharma Inc, uses the company's proprietary precision olfactory delivery technology to deliver DHE (0.725 mg per spray) rapidly to the bloodstream via the vascular-rich upper nasal space. This bypasses the gut and potential absorption problems, the company said in a news release.
As previously reported by Medscape Medical News, results from the phase 3 STOP 301 trial showed that the intranasal formulation of DHE was safe and generally well tolerated over 52 weeks for the acute treatment of migraine.
Some of the most frequently reported adverse events related to the nasal spray during the study were nasal congestion, nausea, nasal discomfort, abnormal olfactory test results, and vomiting.
Exploratory outcomes related to efficacy showed that 2 hours after a single dose, 38% of patients reported freedom from pain. Of this group, 7.1% reported migraine recurrence at 24 hours, and 14.3% reported migraine recurrence at 48 hours.
About 52% of patients reported freedom from their most bothersome symptom at 2 hours post treatment; 66.3% reported pain relief at 2 hours after their first attack treated with the nasal spray.
"We welcome an important new treatment that combines the long-established efficacy of DHE with a non-oral, innovative delivery system that allows patients to self-administer wherever they are and at any point within a migraine attack," Kevin Lenaburg, executive director of the Coalition for Headache and Migraine Patients, in the release.
Overcomes Current Challenges
The newly approved nasal spray "may provide rapid, sustained, and consistent relief, even when taken late into a migraine attack," Adrian Adams, chairman and CEO of Impel NeuroPharma, noted in the press release.
"Many of my patients need more from their migraine treatment, and Trudhesa offers a non-oral, fast-acting, reliable option that overcomes many current medication challenges," Stephanie J. Nahas-Geiger, MD, associate professor, Department of Neurology, Thomas Jefferson University, Philadelphia, Pennsylvania, said in the release.
"Its upper nasal delivery circumvents the GI tract and common phenomena associated with migraine, such as nausea and gastroparesis, that can impact the effectiveness of oral treatments," said Nahas-Geiger.
Importantly, the drug is self-administered in a single dose as needed, "so patients don't need to worry about missing the opportunity to benefit from using Trudhesa within a certain time frame," she added.
The company announced that it plans to launch Trudhesa in early October.
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Cite this: FDA Approves Intranasal DHE (Trudhesa) for Acute Migraine - Medscape - Sep 03, 2021.