Satsuma Pharmaceuticals and SNBL Publish Phase 3 STS101 Study in CNS Drugs

A recent study has shown that the long-term, as-needed use of STS101 for the acute treatment of migraine attacks is both safe and well-tolerated. The exploratory efficacy endpoints revealed that STS101 provided rapid relief from pain in 37% of migraine attacks and rapid relief from the most bothersome symptoms in 54% of attacks within two hours of administration. These benefits were sustained for up to 48 hours after dosing.

Satsuma Pharmaceuticals, Inc., a late-stage biopharmaceutical company, announced the publication of the STS101 ASCEND Phase 3 long-term safety trial in CNS Drugs. Satsuma is currently seeking regulatory approval from the U.S. Food and Drug Administration for STS101, a novel therapeutic product candidate for the acute treatment of migraines. STS101 combines Satsuma's proprietary SMART™ (Simple MucoAdhesive Release Technology) with an easy-to-use nasal delivery device.

Ryoichi Nagata, President and CEO of Satsuma, expressed pride in the pivotal safety data published, highlighting STS101's potential to deliver rapid and sustained symptom relief for patients with acute migraine, subject to FDA approval. The majority of patients found STS101 easy to use throughout the study.

Stewart Tepper, MD, Vice President of the New England Institute for Neurology and Headache in Stamford, Connecticut, also emphasized the significance of the data. He pointed out that STS101 was safe, well-tolerated, and user-friendly over the long term. This finding is particularly important for migraine sufferers who have not experienced adequate relief with existing therapies and for practitioners in need of new treatment options. Despite recent advancements in migraine treatment, there remains a critical need for non-oral options for patients who struggle to achieve rapid relief through oral medications.

The ASCEND Study was a pivotal Phase 3 open-label trial conducted at 54 sites across the United States. It evaluated the safety, tolerability, exploratory efficacy, and patient acceptability of STS101. The study enrolled 482 patients diagnosed with migraines, who experienced 4 to 12 migraine attacks per month in the three months leading up to the study. During the trial, 446 patients received at least one dose of STS101, using a total of 10,137 doses over a period of up to 18 months.

Results showed that STS101 was well-tolerated with treatment-emergent adverse events (AEs) reported in 14.3% of migraine attacks treated. The rate of adverse event-related discontinuation was low at 7%. No new safety signals were observed during the study. 

Patient-reported exploratory efficacy data indicated that two-thirds of patients experienced pain relief within two hours post-administration of STS101. Additionally, a patient global impression questionnaire (PGI) revealed that most patients had a positive overall impression of STS101, found it easy to use, and indicated they would use it if available.

Satsuma Pharmaceuticals, a subsidiary of Shin Nippon Biomedical Laboratories, Ltd. (SNBL), focuses on developing STS101, a unique nasal powder formulation of dihydroergotamine mesylate (DHE) for acute migraine treatment. STS101 is designed for quick and convenient self-administration, offering fast absorption and sustained DHE plasma levels with low dose-to-dose variability.

Satsuma is based in Research Triangle Park, North Carolina. 

Shin Nippon Biomedical Laboratories, Ltd. (SNBL), founded in Kagoshima, Japan, in 1957, is a contract research organization dedicated to supporting drug development and medical technology improvements. SNBL offers a comprehensive range of services for drug discovery and development both in Japan and internationally.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!