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The Good Brigade
Satsuma Prescription drugs (NASDAQ:STSA) migraine remedy STS101 didn’t meet the primary objectives of a section 3 trial and the corporate stated it doesn’t plan to spend money on commercializing STS101 and can discover options to maximise worth and reduce money expenditures.
STS101 is a nasal powder formulation of anti-migraine drug dihydroergotamine mesylate (DHE) administered by way of Satsuma’s proprietary nasal supply machine,
The corporate stated knowledge from the research, dubbed SUMMIT, confirmed that STS101 was not statistically superior to placebo at two hours post-administration on the co-primary objectives of freedom from ache and most bothersome symptom (from amongst photophobia, phonophobia and nausea).
STS101 did, nevertheless, present superiority variations versus placebo on freedom from ache and most bothersome symptom in any respect timepoints after two hours post-administration (3, 4, 6, 12, 24 and 48 hours), and on a number of secondary objectives, together with ache reduction at 2 hours post-administration and all timepoints thereafter, the corporate added.
STS101 confirmed a good security and tolerability profile, in line with trial expertise so far, based on the corporate.
Satsuma stated that based mostly on earlier interactions with the FDA, it believes outcomes from the STS101 section 1 PK (pharmacokinetic) and ASCEND section 3 long-term, security trials will help NDA submitting and approval.
In September, Satsuma reported outcomes from ASCEND, which confirmed the therapy was protected, the primary aim of the trial.
“We’re shocked and upset that STS101 didn’t exhibit statistically important superiority over placebo at two-hours submit therapy on the SUMMIT research co-primary endpoints,” stated Satsuma’s President and CEO John Kollins.
Satsuma famous that it doesn’t plan to spend money on commercializing STS101.
As of Oct. 31, the corporate had estimated money and equivalents of $59.4M.
STSA -80.25% to $0.80 premarket Nov. 14
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