FDA Approves Dihydroergotamine Mesylate Nasal Spray for Acute Migraine Treatment

The nasal spray bypasses the gut and potential absorption issues associated with it, and offers consistent relief even when administered hours after the onset of a migraine attack.

Officials with the FDA have approved dihydroergotamine mesylate nasal spray (Trudhesa; Impel NeuroPharma) for the acute treatment of migraine with or without aura in adults.

The spray delivers the proven, well-established therapeutic dihydroergotamine mesylate into the bloodstream through the vascular-rich upper nasal space. According to a press release, the spray bypasses the gut and potential absorption issues associated with it, offering fast, sustained, and consistent symptom relief. This relief is consistent even when the drug is administered hours after the onset of a migraine.

The company plans to launch the nasal spray in early October of 2021, according to the press release.

“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,” said Adrian Adams, chairman and chief executive officer of Impel NeuroPharma, in the press release.

The approval is based on results from the phase 3, open-label, pivotal STOP 301 trial, which included more than 5650 migraine attacks treated over 24 or 52 weeks. The primary objective was to assess the safety and tolerability of dihydroergotamine mesylate nasal spray and exploratory objectives, including efficacy assessments and a patient acceptability questionnaire.

The results demonstrated that the nasal spray was generally well tolerated and provided rapid, sustained, and consistent symptom relief. Unlike some oral acute treatments that must be taken within 1 hour of migraine onset, the trial found that Trudhesa had consistent efficacy even when taken late into a migraine attack.

“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,” said Stephanie J. Nahas-Geiger, MD, MSEd, program director of the Headache Medicine Fellowship Program at Thomas Jefferson University, in the press release. “Its upper nasal delivery circumvents the [gastrointestinal] tract and common phenomena associated with migraine, such as nausea and gastroparesis, that can impact the effectiveness of oral treatments.”

In the STOP 301 trial, there were no serious drug-related treatment-emergent adverse events (TEAEs) and the majority of TEAEs were mild and transient in nature. Some of the most frequently reported adverse events during the 52-week study period were nasal congestion, nausea, nasal discomfort, abnormal olfactory test, and vomiting.

Patient-reported exploratory efficacy findings showed that 38% of patients had pain freedom, 66% had pain relief, and 52% had freedom from their most bothersome migraine symptoms 2 hours after their first dose of Trudhesa. Additionally, 16% of patients said that pain relief started as early as 15 minutes after their first dose.

Of those who were pain free at 2 hours, 93% were still pain free at 24 hours and 86% were still pain free at 2 days. The majority (84%) of patients reported that the nasal spray was easy to use and said they preferred it over their current therapy.

“Migraine is a disease that impacts the whole body and is the second leading cause of disability,” said Kevin Lenaburg, executive director of the Coalition for Headache and Migraine Patients, in the press release. “Historically there have not been enough effective treatments for treating migraine attacks, especially treatments that are not oral medicines, which can be challenging due to nausea, vomiting, and other [gastrointestinal] symptoms that can occur during a migraine.”

REFERENCE

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 3, 2021. https://impelnp.com/2021/09/03/impel-neuropharma-announces-u-s-fda-approval-of-trudhesa-dihydroergotamine-mesylate-nasal-spray-for-the-acute-treatment-of-migraine/