Nasal Powder Approved by FDA for Treatment of Adults with Acute Migraine

The Food and Drug Administration (FDA) has approved Atzumi (dihydroergotamine [DHE]; Satsuma Pharmaceuticals, Durham, NC) for the treatment of adults with acute migraine with or without aura. Atzumi is a powder formulation designed for intranasal drug delivery via a squeezable device.

FDA approval was based on results from a randomized, open-label, phase 1 pharmacokinetic (PK) study (NCT03874832) and the open-label, long-term, phase 3 ASCEND study (NCT04406649). The PK study (N=43) demonstrated that Atzumi was rapidly absorbed and achieved effective DHE plasma concentrations in treated individuals within 10 minutes after administration.

The ASCEND study included 344 participants with a ≥1 year history of migraine with or without aura, with onset before the age of 50 years and 4–12 migraine attacks per month and <15 headache days per month in each of the 3 months prior to screening. Participants self-administered Atzumi 5.2 mg as needed (up to 2 doses within 24 hours, up to 12 doses per month) to treat a single migraine attack.

At 2, 4, and 24 hours after treatment with Atzumi, respectively, participants experienced:

• Rapid onset of freedom from pain in 36.6%, 67.1%, and 85.5% of treated attacks.
• Freedom from most bothersome symptoms in 54.3%, 79.6%, and 91.3% of treated attacks.
• Headache relief in 66.5%, 89.1%, and 94.3% of treated attacks.

Atzumi includes a Boxed Warning about the risk of peripheral ischemia following coadministration with strong CYP3A4 inhibitors. Atzumi is contraindicated for use in individuals with concomitant use of strong CYP3A4 inhibitors; ischemic heart disease or coronary artery vasospasm; uncontrolled hypertension, peripheral arterial diseases, sepsis, following vascular surgery, or severe hepatic or renal impairment; hypersensitivity to ergot alkaloids; concomitant use of other 5-HT₁ agonists or ergotamine-containing or ergot-type medication within 24 hours; concomitant use of peripheral and central vasoconstrictors.

"DHE plays a unique clinical role in the acute treatment of migraine, providing patients long lasting effects and the unique ability to provide benefit even when taken late in a migraine attack. The convenience of Atzumi, the only DHE nasal powder, will offer patients ease of use combined with the important known DHE clinical advantages", said Stewart J. Tepper, MD, Vice President, New England Institute for Neurology and Headache.