Migraine is a common neurological disease characterized by episodes of severe head pain and associated with nausea, vomiting, sensitivity to light and sound.
A migraine attack can often be preceded by transient neurological warning symptoms, known as auras, which typically involve visual disturbances such as flashing lights, but may also involve numbness or tingling in parts of the body.1
Migraine affects approximately 39 million people in the United States and is the fifth leading cause of years lived with disability.2 Of those diagnosed, only six million are on prescription treatment.3 While triptans account for almost 70 percent of migraine therapies,4 approximately 30 to 40 percent of patients do not respond adequately to triptan therapy5 and up to 79 percent of the patients who do respond to triptans report being dissatisfied with their current treatment and willing to try a new therapy.6
In September 2021, Impel Pharmaceuticals received U.S. Food and Drug Administration (FDA) approval for Trudhesa® (dihydroergotamine mesylate) nasal spray (0.75 mg per spray) for the acute treatment of migraine with or without aura in adults. Trudhesa was previously known as INP104.
The efficacy of currently approved DHE-based medications is well-established and they are widely used as part of the standard of care for the acute treatment of migraine.9 DHE, when reaching satisfactory systemic blood levels, is know to have fast onset and lasting effects for up to 48 hours.10 It may also be effective in other subtypes of migraine including patients who are triptan resistant, those with menstrual migraine, patients experiencing central sensitization and allodynia, and severe and/or prolonged migraine.11, 12, 13, 14 But the broad use of this treatment has been generally limited by its need for intravenous injection delivery, administered in physicians’ offices, migraine clinics and hospitals.
Episodes of severe head pain
Nausea and vomiting
Sensitivity to light
Tingling in parts of the body
Trudhesa gently delivers dihydroergotamine mesylate (DHE)—a proven, well-established therapeutic15 —quickly to the bloodstream through the vascular-rich upper nasal space. Trudhesa bypasses the gut and potential absorption issues, offering the potential for rapid, sustained, and consistent relief without injection or infusion, even when administered hours after the start of a migraine attack.16
1 Mayo Clinic. Migraine Symptoms & Causes. Last Accessed February 3, 2020.
2 2020 Census Redistricting Data (Public Law 94-171). Summary File.
3 R. B. Lipton, M. E. Bigal, M. Diamond, F. Freitag, M. L. Reed, W. F. Stewart. Migraine prevalence, Disease Burden, and the Need for Preventive Therapy. Neurology 2007;68;343-349 DOI: 10.1212/01.wnl.0000252808.97649.21
4 Migraine Research Foundation. Migraine Facts. Last Accessed February 3, 2020.
5 Impel Data on File.
6 Impel Data on File.
7 Viana M, et al. Cephalalgia. 2013 Aug;33(11):891-6
8 Impel Data on File.
9 Marmura MJ, Silberstein SD, Schwedt TJ. Headache. 2015;55(1):3-20
10 Tepper SJ, Kori SH, Goadsby PJ, et al. Mayo Clin Proc. 2011;86:948-955.
11 Aurora S, Lu B, Connors E, Li X, Kellerman D, Kori S. J Headache Pain 2013;14(Suppl 1):P143.
12 Saper JR, Silberstein S, Dodick D, Rapoport A. Headache. 2006;46 Suppl 4:S212-220.
13 Tepper SJ, Kori SH, Goadsby PJ, Winner PK, Wang MH, Silberstein SD, Cutrer FM. Mayo Clin Proc. 2011;86(10):948-955.
14 Kori S, Connors E, Zhou J, Lu B, Borland S. J Headache Pain 2013a;14(Suppl 1):P208.
15 U.S. Food & Drug Administration. FDA-Approved Drugs: D.H.E. 45. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=005929 1 — U.S. Food & Drug Administration. FDA-Approved Drugs: Migranal. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020148
16 Aurora SK, et al. J Headache Pain. 2013;14(Suppl 1):P143.