FDA approves DHE-based migraine treatment Trudhesa

The FDA approved dihydroergotamine mesylate for the treatment of adults with acute migraine with or without aura, according to a press release from the drug’s manufacturer.

Dihydroergotamine mesylate (Trudhesa, Impel NeuroPharma) is a nasal spray that, via a Precision Olfactory Delivery system, provides 0.725 mg of the medication with each spray.

The dihydroergotamine mesylate then “bypasses the gut and potential absorption issues, offering rapid, sustained, and consistent symptom relief without injection or infusion, even when administered hours after the onset of a migraine attack,” the press release stated.

“Trudhesa offers a nonoral, fast-acting, reliable option that overcomes many current medication challenges,” Stephanie J. Nahas-Geiger, MD, MSEd, program director of the Headache Medicine Fellowship Program at Thomas Jefferson University in Philadelphia, said in the release. “I think patients will be very receptive to this treatment, because it pairs the long-proven benefits of [dihydroergotamine] with a patient-friendly delivery system.”

Impel NeuroPharma stated in the press release that among patients with migraine who received dihydroergotamine mesylate in a 52-week trial, 38% reported pain freedom, 66% reported pain relief and 52% had freedom from their most bothersome migraine symptom 2 hours after taking the medication (with 93% still “pain-free” at 24 hours and 86% without pain 2 days later). In addition, 16% experienced pain relief in as few as 15 minutes, the press release continued.

Only mild and transient treatment-emergent adverse events related to dihydroergotamine mesylate’s use occurred, according to investigators. These events included nasal congestion, reported by 17.8% of patients; nausea, nasal discomfort and abnormal olfactory test, each reported by 6.8% of patients; and vomiting, reported by 2.7% of patients.

Kevin Lenaburg, executive director of the Coalition for Headache and Migraine Patients, applauded dihydroergotamine mesylate’s approval.

“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 GI symptoms that can occur during a migraine,” he said in the release.

“We welcome an important new treatment that combines the long-established efficacy of [dihydroergotamine] with a nonoral, innovative delivery system that allows patients to self-administer wherever they are and at any point within a migraine attack,” Lenaburg continued.

The commercial launch of dihydroergotamine mesylate is planned for early October, according to the press release.