Dihydroergotamine mesylate nasal spray receives FDA approval for the acute treatment of migraine in adults

On September 3, 2021, the United States Food and Drug Administration (FDA) approved TRUDHESA™ (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura in adults. Dihydroergotamine mesylate (DHE) uses a proprietary Precision Olfactory Delivery (POD^®) technology to deliver DHE into the bloodstream through the upper nasal space in the treatment of acute migraine attacks.

Previous formulations of DHE are known to be effective for migraine.¹ This approval offers patients with migraine a different formulation of DHE as a non-oral, acute treatment option that may bypass the gut and potential absorption issues associated with some oral options that may be less effective when taken too late in the attack. DHE, on the other hand, may remain efficacious even if administered hours later regardless of pain intensity.

Clinical Trial²

FDA approval was based on the results of the STOP 301 Phase 3, open-label study of safety, tolerability, and exploratory efficacy: the largest longitudinal study conducted with DHE delivered by nasal spray. At the end of the 24-week trial period, no new safety signals were observed following delivery to the upper nasal space. DHE-related adverse events (AEs) were reported in 36.7% of patients with 6.8% reporting nausea specifically; and 6.8% of patients discontinued treatment due to AEs over 24 weeks.

Additionally, patients self-reported pain freedom (38%), pain relief (66%), and relief from their most bothersome migraine symptom (52%). Pain relief started as early as 15 minutes in 16% of patients, while 84% reported that DHE nasal spray was easy to use and preferred it over their current therapy.

See the full study published on Headache.

This article is notice of a new approval, not intended to be an endorsement of a particular product and/or treatment modality.

References: 1. Marmura MJ, Silberstein SD, Schwedt TJ. The acute treatment of migraine in adults: the American Headache Society evidence assessment of migraine pharmacotherapies. Headache. 2015;55(1):3-20. 2. Smith TR, Winner P, Aurora SK, et al. STOP 301: a phase 3, open-label study of safety, tolerability, and exploratory efficacy of INP104, Precision Olfactory Delivery (POD^®) of dihydroergotamine mesylate, over 24/52 weeks in acute treatment of migraine attacks in adult patients. Headache. Published online August 7, 2021. doi: 10.1111/head.14184.