Satsuma Pharmaceuticals and SNBL Secure FDA Review for Migraine Treatment STS101

• Satsuma Pharmaceuticals and Shin Nippon Biomedical Laboratories (SNBL) announced FDA acceptance of the resubmitted NDA for STS101, a dihydroergotamine nasal powder for acute migraine treatment.

Satsuma Pharmaceuticals, Inc., a late-stage biopharmaceutical company, along with its parent company Shin Nippon Biomedical Laboratories, Ltd. (SNBL), a contract research organization has confirmed that the U.S. Food and Drug Administration (FDA) has accepted its resubmitted New Drug Application (NDA) for STS101. This investigational dihydroergotamine nasal powder is designed for the acute treatment of migraines, with or without aura.

The FDA’s acceptance follows Satsuma’s resubmission in response to the agency’s January 2024 Complete Response Letter. The Prescription Drug User Fee Act (PDUFA) date, marking the FDA’s decision deadline, is set for 30 April 2025.

According to Satsuma, migraines affect nearly 40 million people in the United States, particularly women aged 20 to 40. The acute migraine medication market in the U.S. is estimated at over USD 1 billion, presenting significant potential for STS101 if approved.