US FDA accepts Satsuma’s 505(b)(2) NDA for STS101

The US Food and Drug Administration (FDA) has accepted Satsuma Pharmaceuticals’ 505(b)(2) new drug application (NDA) for STS101 for acute treatment of migraine, for review.

The new investigational therapeutic product candidate STS101 is a nasal powder formulation of dihydroergotamine mesylate (DHE), an anti-migraine drug, which is given through the company’s nasal delivery device.

It provides significant benefits compared to the current acute treatments for migraine.

The prescription drug user fee act (PDUFA) date is expected to be set as January 2024.

Satsuma Pharmaceuticals stated that its product candidate showed fast high DHE plasma concentrations, believed to be necessary for efficacy and to be below those DHE plasma levels associated with adverse events, including vomiting and nausea.

Satsuma Pharmaceuticals president and CEO 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, safe and well-tolerated DHE treatment that can address the significant unmet clinical needs of many people with migraine.”

The company’s NDA was supported mainly by the data obtained from the Phase I clinical trial completed in June 2021, and the Phase III ASCEND trial.

In the long-term, open-label, safety ASCEND trial, 446 participants with more than 9,000 migraine attacks were treated with more than 10,500 STS101 doses for up to 18 months.  

Findings from the double-blind placebo-controlled Phase III SUMMIT trial were included in the NDA.