FDA Clears Novel Nasal Spray for Migraine

The therapy, to be launched in October, is delivered quickly to the bloodstream by targeting the upper nasal space.

The FDA has approved Trudhesa (dihydroergotamine mesylate), a nasal spray for the acute treatment of migraine with or without aura in adults.

Trudhesa was developed by Impel NeuroPharma. The therapy 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,” Impel said in a news release.The wholesale acquisition cost (WAC) of Trudhesa will be $850 per pack of four doses. "We believe this price will be very competitive with the newer gepant products, which are priced on a comparable level in the $890 range,” Adrian Adams, chairman and CEO of Impel NeuroPharma, told FormularyWatch.

"The value of Trudhesa is further reinforced by the fact that most patients on Trudhesa can get pain relief with one single dose, whereas about 40% of patients using gepants need a second dose. In addition, we have health economic data that shows a reduction in urgent care visits and hospitalization visits among patients using Trudhesa, which further supports the value that Trudhesa will deliver."

Gepants are small molecule calcitonin gene-related peptide (CGRP) receptor antagonists.

Impel is launching the nasal spray in early October. Trudhesa will be available through Trudhesa Direct, a pharmacy partnership and copay program. The digital pharmacy fulfilment partners, Phil Inc. and Carepoint Pharmacy, will provide electronic prescribing and automatic enrollment in the patient savings program for eligible, commercially insured patients without the need for a paper copay card.

“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, M.D., associate professor in the department of neurology and program director of the Headache Medicine Fellowship Program at Thomas Jefferson University, said in the statement.

The medication’s 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,” Nahas added. “And, importantly, it is a self-administered, single dose that can be taken anytime during a migraine attack, so patients don’t need to worry about missing the opportunity to benefit from using Trudhesa within a certain timeframe.”

The new drug application for Trudhesa included the results of a large phase 3, open-label, pivotal safety study. More than 5,650 migraine attacks were treated over 24 or 52 weeks during the study.

More than a third of patients (38%) had pain freedom, according to the self-reported exploratory findings, while 66% had pain relief, and 52% had freedom from their most bothersome migraine symptom at two hours after their first dose of Trudhesa.

Pain relief started as early as 15 minutes for 16% of patients. Of patients who were pain free at two hours, 93% were still pain free at 24 hours and 86% were still pain free through two days.

In addition, Trudhesa was generally well tolerated. There were no serious Trudhesa-related treatment-emergent adverse events observed in the phase 3 study and the majority were mild.

The majority of patients (84%) reported that Trudhesa was easy to use and they preferred it over their current therapy.

According to one study, the prevalence of migraine and severe headache in the United States has remained stable. In 2018, the age-adjusted prevalence was 15.9% across all adults.