Durham-based Satsuma wins FDA approval for migraine treatment

Following a regulatory setback last year, Satsuma Pharmaceuticals Inc. has won approval for its nasal powder migraine treatment device from the U.S. Food and Drug Administration.

Satsuma, a unit of a Japanese drugmaker with U.S. headquarters in Durham, said its treatment, called Atzumi, received its new drug application approval from the FDA. The approval covers Atzumi for the treatment of acute migraine in adults, both with and without aura, or sensory disturbances that sometimes accompany migraine.

The FDA initially declined to approve the new drug application Satsuma filed in 2023 for Atzumi, then known as STS101. The regulatory agency cited issues with chemistry, manufacturing and controls (CMC) data the company had submitted.

In a January 2024 statement, Satsuma’s parent, Shin Nippon Biomedical Ltd., said the FDA didn’t indicate concerns about clinical data. The FDA didn’t request new clinical trials. Satsuma and its parent resubmitted their application in October.

Atzumi is a device that includes Satsuma’s formulation of a standard, decades-old migraine treatment called dihydroergotamine (DHE). The device is designed to give migraine sufferers an easy-to-use treatment option that can fit in a pocket or purse.

About 39 million Americans and about 1 billion people worldwide experience migraine, according to the American Migraine Foundation.

“We believe that Atzumi will contribute to improving the quality of life of patients struggling for relief from these highly disabling problems,” Satsuma president and CEO Ryoichi Nagata said in a statement.

Current migraine treatments with DHE have limitations, Satsuma said, such as nasal sprays and injectables that are difficult to administer or sometimes don’t perform well. In two clinical studies, Atzumi demonstrated fast absorption and sustained presence of DHE in patients and achieved safety and tolerability levels, Satsuma said.

“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,” Stewart Tepper, MD, of the New England Institute for Neurology and Headache, said in the Satsuma statement.

Satsuma rented office space at the North Carolina Biotechnology Center’s Landing Pad before moving to Durham in 2019. The company’s offices are on Emperor Boulevard near Page Road.