( MENAFN - PR Newswire) DURHAM, N.C., Oct.
30, 2024 /PRNewswire/ -- Satsuma Pharmaceuticals, Inc., a late-stage biopharmaceutical company, and its corporate parent, Shin Nippon Biomedical Laboratories, Ltd. (TSE:2395), today announced the resubmission of the new drug application (NDA) for the investigational product STS101 (dihydroergotamine nasal powder) for the acute treatment of migraine with or without aura.
The U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) in January 2024 for the original NDA submitted in March 2023.
After a Type A meeting to discuss the contents of the CRL, Satsuma and SNBL believe the NDA resubmission addresses all findings in the CRL. In the prior CRL, the FDA noted no concerns related with the clinical trial results, including the safety of STS101, and did not request additional clinical trials. However, the Agency provided additional comments primarily related to formulation (Chemistry, Manufacturing, and Control - CMC).
"The resubmission of the STS101 NDA resubmission is a critical step in our mission to bring this unique and new therapy to patients experiencing migraine who often have inadequate treatment options," said Ryoichi Nagata, President and CEO of Satsuma, M.D., Ph.
D., FFPM. About Satsuma and STS101 Satsuma Pharmaceuticals, a wholly-owned subsidiary of Shin Nippon Biomedical Laboratories, Ltd.
(SNBL), is a late-stage biopharmaceutical company that is currently seeking regulatory approval from the U.S. Foo.
