Satsuma Pharmaceuticals (NASDAQ:STSA) stock rose ~5% on Sept. 20 after the company said STS101 showed a favorable safety and tolerability profile in an ongoing phase 3 trial in patients with migraine.
STS101 is a nasal powder formulation of anti-migraine drug dihydroergotamine mesylate (DHE) administered via Satsuma’s proprietary nasal delivery device, the company said in a Sept. 20 press release.
The main goal of the trial, dubbed ASCEND, is to test the safety and tolerability of STS101 in the acute treatment of migraine attacks over six and 12 months. A secondary goal is to assess the efficacy of STS101.
The company said that among 172 trial participants who treated 1,932 migraine attacks exclusively with STS101, freedom from pain by 2 hours post-treatment was seen in 34.2% of all treated attacks.
Freedom from most-bothersome-symptom by 2 hours post-therapy was seen in 53.4% of all treated attacks, the company added.
Satsuma added that in more than 81% of treated attacks, people did not report using an allowed second dose of STS101 within 48 hours of administering the first dose.
Among 344 people who self-administered at least one dose of STS101, and in total more than 6,900 doses, for up to 18 months, no clinically relevant nasal safety or tolerability findings or unexpected treatment-related serious adverse events were reported, according to the company.
Treatment-emergent adverse events (TEAEs) reported among 5% or more of people or in 5% or more of attacks treated with STS101 were seen.
Nasal discomfort occurred in 11% of people. TEAEs were typically mild (82.7%) and transient, Satsuma noted.