Trudhesa nasal spray shows efficacy for migraines in phase 3 trial

DENVER — Trudhesa nasal spray provided pain relief for up to three consecutive migraine attacks in an open-label, 52-week phase 3 trial, researchers said at the American Headache Society annual scientific meeting.

Trudhesa (dihydroergotamine mesylate, Impel Pharmaceuticals) uses Precision Olfactory Delivery technology for rapid absorption and bioavailability of the drug, the company said in a press release. Nasal delivery allows the therapeutic to bypass the gut and reduces potential absorption issues, while offering consistent symptom relief without nausea.

“These data suggest that patients who respond to Trudhesa during the first two migraine attacks will continue to respond long-term,” Sara Sacco, MD, a neurologist at Carolinas Headache Clinic in Charlotte, N.C., and lead author of the study, said in the release. “This, coupled with the new analysis showing self-reported improvements in disability and headache days with long-term Trudhesa use, equips clinicians with new information to improve therapeutic decision making, especially for non-responders to triptans or medications targeting calcitonin gene-related peptide, or CGRP.”

According to the analysis, participants who self-reported mild or no pain at 2 hours for their first three Trudhesa-treated migraines were more than 89% likely to respond to this treatment. Those with mild or no pain for their first two treatments were more than 75% likely to respond.

“Patients are seeing relief of symptoms, improved predictability of response to treatment and a reduction of disabilities due to their migraine with Trudhesa,” Sacco said.