FDA Accepts Satsuma Pharmaceuticals' NDA for STS101 Migraine Treatment
核心洞察
The FDA has accepted Satsuma Pharmaceuticals (搜索)' 505(b)(2) NDA for STS101, a novel nasal powder formulation of dihydroergotamine mesylate (DHE (搜索)) for acute migraine (搜索) treatment.
STS101 is designed for easy self-administration and rapid achievement of high drug plasma levels, potentially offering advantages over existing DHE (搜索) products.
The NDA is supported by Phase 1 and Phase 3 trial results, including the SUMMIT trial, which demonstrated robust and sustained effects on migraine (搜索) endpoints.
Satsuma Pharmaceuticals (搜索) announced that the FDA has accepted its 505(b)(2) New Drug Application (NDA) for STS101, an investigational therapeutic for the acute treatment of migraine (搜索). The FDA's acceptance marks a significant step toward potentially providing a new treatment option for individuals suffering from migraine. The expected PDUFA date is in January 2024.
STS101: A Novel Approach to Migraine Treatment
STS101 is a unique nasal powder formulation of dihydroergotamine mesylate (DHE (搜索)), administered via a proprietary nasal delivery device. Satsuma designed STS101 to be easily portable and self-administered within seconds, without the need for complex administration procedures. This design aims to rapidly achieve high drug plasma levels, thought to be necessary for robust efficacy while remaining below levels associated with adverse events like nausea and vomiting.
John Kollins, President and CEO of Satsuma, 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 (搜索) treatment that can address the significant unmet clinical needs of many people with migraine (搜索)."
Clinical Trial Data Supporting the NDA
The STS101 NDA is primarily supported by data from a Phase 1 comparative pharmacokinetic and safety trial completed in June 2021, and the ASCEND Phase 3 long-term, open-label safety trial. In the ASCEND trial, 446 subjects treated over 9,000 migraine (搜索) attacks with more than 10,500 doses of STS101 for up to 18 months.
Although not required for approval, results from the SUMMIT Phase 3 double-blind, placebo-controlled efficacy trial involving 1,600 subjects are also included in the NDA. While STS101 demonstrated numerical but not statistical significance on the primary outcome measures (% of subjects free from pain and % of subjects free from most-bothersome-symptom at two hours post-dose), it did show robust and sustained effects (p<0.001) on those endpoints at all post-dose time points after two hours (3, 4, 6, 12, 24, and 48 hours). STS101 also demonstrated robust and sustained antimigraine effects across numerous secondary endpoints recommended for assessment in efficacy trials by the FDA and the International Headache Society.
Acquisition by SNBL
Satsuma Pharmaceuticals (搜索) announced on April 16, 2023, that it had entered into a definitive agreement to be acquired by Shin Nippon Biomedical Laboratories, Ltd. (SNBL).