US late-stage biopharmaceutical company Satsuma Pharmaceuticals Inc and its corporate parent, Japan-based Shin Nippon Biomedical Laboratories, Ltd. (TSE:2395), announced on Wednesday that they have resubmitted the new drug application (NDA) to the US Food and Drug Administration (FDA) for the investigational product STS101 (dihydroergotamine nasal powder) intended for the acute treatment of migraine with or without aura.

The FDA issued a complete response letter (CRL) in January 2024 for the original NDA submitted in March 2023. Following a Type A meeting to discuss the contents of the CRL, both companies believe the NDA resubmission deals with all findings in the CRL.

In the prior CRL, the FDA stated no concerns associated with the clinical trial outcome, which includes the safety of STS101, and did not request additional clinical trials; however the agency added comments mainly related to formulation (Chemistry, Manufacturing, and Control - CMC).

Satsuma president and CEO Ryoichi Nagata MD, PhD, FFPM, said: "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."