South San Francisco - Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a development-stage biopharmaceutical company today announced that its 505(b)(2) new drug application (NDA) for STS101, a novel and investigational therapeutic product candidate for the acute treatment of migraine, has been accepted for review by the FDA.

Satsuma's President and Chief Executive Officer, John Kollins, stated, 'We are proud to announce the FDA acceptance for review of our STS101 NDA, as it represents an important milestone for our company and an important step toward achieving our goal of making STS101 available as an easy-to-use, effective, and safe and well-tolerated DHE treatment that can address the significant unmet clinical needs of many people with migraine.'

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

Although not required for approval based on Satsuma's communications with the FDA, results from the 1,600-subject STS101 SUMMIT Phase 3 double-blind, placebo-controlled efficacy trial are also included in the NDA. Satsuma announced topline SUMMIT trial results in November 2022 and subsequently announced further results in December 2022. Although STS101 demonstrated numerical, but not statistical significance on SUMMIT trial primary outcome measures (% of subjects free from pain and % of subjects free from most-bothersome-symptom1 at two hours post-dose), STS101 did demonstrate robust and sustained effects (p

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