Pharma Focus America

FDA Accepts Satsuma Pharmaceuticals' 505(b) (2) NDA for STS101: A Promising Investigational Dihydroergotamine (DHE) Nasal Powder for Acute Migraine Treatment

Satsuma Pharmaceuticals, a development-stage biopharmaceutical company (Nasdaq: STSA), has announced that the U.S. Food and Drug Administration (FDA) has accepted its 505(b) (2) new drug application (NDA) for STS101. STS101 is a novel and investigational therapeutic product candidate aimed at treating acute migraines.

John Kollins, President and CEO of Satsuma Pharmaceuticals, expressed his pride in the FDA's acceptance of the STS101 NDA. He sees it as a significant milestone for the company and an important step towards making STS101 available to address the unmet clinical needs of migraine sufferers.

The STS101 NDA is primarily supported by clinical trial data, including results from the Phase 1 comparative pharmacokinetic and safety trial completed in June 2021. Additionally, the NDA includes data from the STS101 ASCEND Phase 3 long-term, open-label safety trial, where over 446 subjects treated more than 9,000 migraine attacks with over 10,500 doses of STS101 for up to 18 months.

While not required for approval, the NDA also incorporates results from the STS101 SUMMIT Phase 3 double-blind, placebo-controlled efficacy trial, and involving 1,600 subjects. Although STS101 demonstrated numerical but not statistical significance on the primary outcome measures of the SUMMIT trial (% of subjects free from pain and % of subjects free from the most bothersome symptom one at two hours post-dose), it showed robust and sustained effects at all post-dose timepoints after two hours (3, 4, 6, 12, 24, and 48 hours) with statistical significance (p<0.001). STS101 also exhibited significant antimigraine effects across various secondary endpoints recommended by the FDA and the International Headache Society's guidelines for controlled trials of acute treatment of migraine attacks.

In addition to the FDA acceptance news, Satsuma Pharmaceuticals announced its definitive agreement to be acquired by Shin Nippon Biomedical Laboratories, Ltd. (SNBL). The acquisition involves a cash offer of $0.91 per share at the closing of the transaction, along with a contingent value right (CVR) of up to $5.77 per share. The CVR holders will receive payments based on the proceeds received by SNBL from any future transaction involving STS101. SNBL initiated a tender offer for Satsuma on May 5, 2023, which is set to expire at the end of June 5th, unless extended or terminated earlier.

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