The U.S. Food and Drug Administration (FDA) has announced the approval of Trudhesa nasal spray (dihydroergotamine mesylate) for the acute treatment of migraine in adults, with or without aura, according to Global News Wire.
Seattle-based Impel NeuroPharma received the FDA approval for the product, which is expected to be launched in October.
Trudhesa is quickly and gently delivered to the bloodstream through the vascular-rich upper nasal space. The drug 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, per the news outlet.
Chairman & CEO of Impel NeuroPharma Adrian Adams said, “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.”
“The approval of Trudhesa marks the culmination of more than a decade of research and advanced engineering to pair the proven efficacy of DHE with our innovative POD technology,” he added. “We are grateful for all the patients and investigators who participated in our clinical trials and who were instrumental in bringing this needed advancement to the migraine community.”
Dr. Stephanie Nahas-Geiger, a Jefferson University physician, said, “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.”
“Its 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,” she 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.
“I think patients will be very receptive to this treatment, because it pairs the long-proven benefits of DHE with a patient-friendly delivery system,” Dr. Nahas-Geiger explained.
There have been no serious side effects reported after the use of Trudhesa; however, some of the common adverse events reported during trials include nausea, vomiting, nasal congestion, nasal discomfort, and abnormal olfactory test.
Trudhesa will be available through Trudhesa Direct, a pharmacy partnership, and copay program. Online drugstores, such as Phil Inc. and Carepoint Pharmacy, will provide e-prescriptions.