- Satsuma Pharmaceuticals Inc (NASDAQ:STSA) announced positive Pharmacokinetic and safety results from a Phase 1 trial of STS101 (dihydroergotamine (DHE) nasal powder).
- The data showed that all three dose strengths (5.2 mg and two higher dose strengths) administered with Satsuma's nasal delivery device were well-tolerated and achieved the target pharmacokinetic profile.
- Based on these results and other data, Satsuma is initiating its SUMMIT Phase 3 efficacy trial with the 5.2 mg dosage strength of STS101.
- The trial will enroll approximately 1,400 migraine patients.
- Two co-primary endpoints of the SUMMIT trial are freedom from pain and freedom from most bothersome symptoms at two hours after STS101 administration.
- Topline results from the SUMMIT trial are expected in the second half of 2022.
- In September 2020, a similar Phase 3 EMERGE trial with STS101 failed to achieve freedom from pain and the most bothersome symptom in migraine patients.
- Price Action: STSA shares are up 8.08% at $5.35 during the premarket session on the last check Thursday.
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