Satsuma Pharmaceuticals and SNBL Resubmit NDA for STS101 Migraine Treatment

On October 30, 2024, Satsuma Pharmaceuticals, Inc., an advanced-stage biopharmaceutical firm, along with its parent company Shin Nippon Biomedical Laboratories, Ltd. (SNBL) (TSE:2395), announced the resubmission of a new drug application (NDA) for their investigational product, STS101. This product is a dihydroergotamine nasal powder intended for the acute treatment of migraines, with or without aura.

The initial NDA, submitted in March 2023, received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) in January 2024. Following a Type A meeting to address the CRL's concerns, Satsuma and SNBL are confident that their resubmission adequately addresses all the findings noted by the FDA.

The FDA's original CRL did not raise any issues regarding the clinical trial outcomes or the safety profile of STS101, nor did it request additional clinical trials. The primary feedback from the FDA was centered around formulation specifics, particularly Chemistry, Manufacturing, and Control (CMC) aspects.

Ryoichi Nagata, President and CEO of Satsuma, emphasized the importance of this resubmission, stating, "The resubmission of the STS101 NDA is a crucial step in our mission to provide new treatment options for patients suffering from migraines, who often have inadequate remedies."

Satsuma Pharmaceuticals, a subsidiary of SNBL, focuses on developing innovative therapeutic solutions for the treatment of migraines. STS101, their flagship product, is a proprietary nasal powder formulation of dihydroergotamine mesylate (DHE), which has long been used for migraine relief. STS101 is designed for rapid and convenient self-administration through a unique nasal delivery device developed by Satsuma. Clinical studies have shown that this nasal powder formulation ensures quick absorption, rapid attainment of high DHE plasma levels, sustained concentrations over time, and minimal dose-to-dose variability.

Satsuma Pharmaceuticals is based in Research Triangle Park, North Carolina.

Shin Nippon Biomedical Laboratories, Ltd. (SNBL), listed on the Tokyo Stock Exchange under the ticker TSE:2395, is a renowned contract research organization (CRO) established in 1957 in Kagoshima, Japan. SNBL's mission is to support drug development and medical technology advancements, aiming to alleviate human suffering. As Japan's oldest and most established CRO, SNBL offers a comprehensive range of services and solutions for drug discovery and development to pharmaceutical companies, biotech firms, universities, and research institutions both domestically and internationally.

The Translational Research Business of SNBL focuses on drug discovery and the development and out-licensing of proprietary intranasal drug delivery technologies and devices. Additionally, SNBL operates the Medipolis Business, which leverages 900 acres of land, primarily forest, in Ibusuki-City, Kagoshima Prefecture. This business promotes local economic and environmental sustainability through geothermal power generation and hospitality services, including a Proton Center for cancer treatment. The Medipolis initiative aims to enhance the well-being, quality of life, and happiness of the local community.

By resubmitting the NDA for STS101, Satsuma Pharmaceuticals and SNBL are advancing towards providing a new, efficient treatment for migraine patients. This resubmission represents a significant step in addressing the unmet needs in migraine therapy and highlights the commitment of both companies to improving patient care through innovative solutions.