FDA Accepts Satsuma and SNBL's Resubmitted NDA for STS101 Migraine Treatment

Satsuma Pharmaceuticals, Inc., a late-stage biopharmaceutical company based in Durham, North Carolina, along with its parent company, Shin Nippon Biomedical Laboratories, Ltd. (SNBL), recently announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of their original new drug application (NDA) for STS101. This investigational product is a nasal powder formulation of dihydroergotamine mesylate (DHE) intended for the acute treatment of migraine with or without aura. This step is a response to a complete action letter received in January 2024.

The Prescription Drug User Fee Act (PDUFA) date for the FDA's decision on the resubmitted NDA is set for April 30, 2025. This milestone brings hope to the nearly 40 million Americans who suffer from migraines, a condition particularly common among women in their 20s to 40s. The market for acute migraine medications in the U.S. is substantial, valued at over USD 1 billion.

Satsuma Pharmaceuticals is a subsidiary of SNBL and is focused on developing STS101, a novel therapeutic designed for the swift and convenient self-administration of migraine relief. STS101 leverages a proprietary nasal delivery device that enables rapid absorption of DHE, leading to quick relief of migraine symptoms. Clinical trials have shown that this formulation allows for the rapid achievement of high plasma concentrations of DHE, maintains these levels over time, and minimizes variability between doses.

SNBL, the parent company, is a well-established contract research organization (CRO) founded in 1957 in Kagoshima, Japan. SNBL has a long history of supporting drug development and advancing medical technologies to alleviate human suffering. As Japan's oldest and most established CRO, SNBL provides a wide range of services and solutions for pharmaceutical companies, biotech ventures, universities, and research institutions both domestically and internationally. SNBL's Translational Research Business focuses on drug discovery, particularly in the development and licensing of intranasal drug delivery technologies and devices.

Additionally, SNBL operates the Medipolis Business, which utilizes 900 acres of land in Ibusuki-City, Kagoshima, for economic and environmental development. This includes geothermal power generation and hospitality services, such as the Proton Center for cancer treatment. The Medipolis Business aims to enhance the well-being, quality of life, and happiness of the community.

In summary, the acceptance by the FDA to review the resubmitted NDA for STS101 marks a significant advancement for Satsuma Pharmaceuticals and its ongoing efforts to provide effective migraine treatments. The anticipated decision date in April 2025 is a beacon of hope for millions of migraine sufferers in the United States, highlighting the continued innovation and commitment of both Satsuma and SNBL in the field of medical science and patient care.