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 migraine attack,” said Adrian Adams, Chairman and Chief Executive Officer of Impel NeuroPharma. “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.”1

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

Migraine is a disease that impacts the whole body and is the second leading cause of disability,” said Kevin Lenaburg, executive director of the Coalition for Headache and Migraine Patients. “Historically there have not been enough effective treatments for treating migraine attacks, especially treatments that are not oral medicines, which can be challenging due to nausea, vomiting and other GI symptoms that can occur during a migraine. We welcome an important new treatment that combines the long-established efficacy of DHE with a non-oral, innovative delivery system that allows patients to self-administer wherever they are and at any point within a migraine attack.”1

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

Migraines are often comorbid with psychiatric disorders, especially mood and anxiety disorders.3 Although the exact nature of the comorbidity is unknown, several mechanistic hypotheses have been considered, including serotonergic dysfunction, ovarian hormone influences in women, and processes perpetuating central sensitization. Similarly, behavioral factors can influence the onset and course of headaches. 

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. https://www.globenewswire.com/news-release/2021/09/03/2291459/0/en/Impel-NeuroPharma-Announces-U-S-FDA-Approval-of-TRUDHESA-Dihydroergotamine-Mesylate-Nasal-Spray-for-the-Acute-Treatment-of-Migraine.html

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. 2021;00:1-13.

3. Smitherman TA, Penzien DB, Rains JC. Migraine and psychiatric comorbidity. Psychiatric Times. 2013;(30)1. Accessed September 3, 2021. www.psychiatrictimes.com/view/migraine-and-psychiatric-comorbidity