FDA nod for Satsuma migraine drug Atzumi

Clinical-stage biopharma company Satsuma Pharmaceuticals and its corporate parent, Shin Nippon Biomedical (TYO: 2395), announced that they have received US Food and Drug Administration (FDA) approval for Atzumi (dihydroergotamine (DHE)) nasal powder for the acute treatment of migraine with or without aura in adults. Atzumi was previously known as STS101.

The approval was based on data from a Phase I pharmacokinetics trial and the Phase III ASCEN trial, which demonstrated fast absorption, as well as high and sustainable levels of DHE plasma concentration. Atzumi was shown to be safe in individuals with migraine, with the drug providing pain relief within two hours in more than a third of the participants.

The North Carolina-based company's marketing application for Atzumi was previously rejected by the FDA last year. The complete response letter cited chemistry, manufacturing and control concerns, but did not indicate any issues with the data or request any new clinical trials.