
Nasal Spray for Treatment of Migraine Approved by FDA
The first and only treatment to use proprietary precision olfactory delivery technology to deliver DHE to the upper nasal cavity just received FDA approval.
The US Food and Drug Administration (FDA) has approved Impel NeuroPharma’s Trudhesa (dihydroergotamine mesylate [DHE]) nasal spray for the acute treatment of migraine with or without aura in adults.
Trudhesa is the first and only therapeutic to use Impel’s proprietary precision olfactory delivery (POD) technology to deliver DHE quickly to the bloodstream through the upper nasal canal, thus offering rapid and sustained symptom relief without injection or infusion. Symptom relief is consistent even when administered long after the onset of a migraine attack.
“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
In the phase 3, open-label, pivotal safety study, STOP 301, which is the largest longitudinal study ever conducted with DHE using nasal spray delivery, two-thirds of 360 participants with migraine had pain relief 2 hours after being treated with Trudhesa with more than 5650 migraine attacks treated. For 1 in 6 patients, pain relief started as early as 15 minutes.2
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Stephanie J. Nahas-Geiger, MD, MSEd, Associate Professor in the Department of Neurology and Program Director of the Headache Medicine Fellowship Program at Thomas Jefferson University, commented: “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. 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.”1
The Commercial launch of TRUDHESA is planned for early October 2021.
References
1. Impel Neuropharma. Impel NeuroPharma announces US FDA approval of Trudhesa (dihydroergotamine mesylate) nasal spray for the acute treatment of migraine. News release. September 3, 2021.
2. Smith TR, Winner P, Aurora SK, et al.
3. Smitherman TA, Penzien DB, Rains JC. Migraine and psychiatric comorbidity. Psychiatric Times. 2013;(30)1. Accessed September 3, 2021.
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