NDA for anti-migraine nasal powder to undergo FDA review

The FDA has accepted for review a 505(b)(2) new drug application for STS101, a novel, investigational nasal powder for the acute treatment of migraine.

The powder is a formulation of the anti-migraine drug dihydroergotamine (DHE) mesylate, which is administered with a proprietary nasal delivery device, according to a press release from its maker, Satsuma Pharmaceuticals.

The treatment is intended to be a quicker and more convenient method of self-administration than current DHE liquid nasal sprays and injectables.

The company’s NDA is backed by results from two clinical trials: a phase 1 comparative pharmacokinetic and safety trial completed in June 2021 and the ASCEND phase 3 long-term, open-label safety trial, during which 446 patients treated more than 9,000 migraine attacks with more than 10,500 doses of STS101 for up to 18 months, the release stated.

Though not required by the FDA, the application also included results from the SUMMIT phase 3 trial, in which STS101 showed numerical but not statistical significance on primary endpoints of freedom from pain and most bothersome symptoms of migraine. Satsuma stated that the investigational therapeutic demonstrated “robust and sustained effects” on the endpoints up to 48 hours after dosing, as well as on “numerous secondary endpoints.”

Satsuma’s president and CEO, John Kollins, said in the release that the acceptance is an “important milestone” toward “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.”