Satsuma Pharmaceuticals is building the case for its nasally administered migraine therapy ahead of a planned filing for FDA approval early next year, reporting results from an ongoing open-label, long-term safety trial.
The failure of a phase 3 clinical trial of the dry-powder dihydroergotamine formulation, STS101, in 2020 dented hopes for the drug candidate. However, Satsuma pushed ahead after identifying variability in the amount of drug administered to patients as a potential cause of the failure, leading it to tweak its nasal delivery device and kick off another phase 3 study.
Ahead of the anticipated release of the phase 3 data in the fourth quarter, Satsuma has shared updated results from a study that got underway before it switched to the second-generation delivery device. The study is assessing the 12-month safety and tolerability of STS101.
In the latest update, the company revealed that more than 10,000 doses of STS101 have been delivered to treat more than 8,000 attacks’ Almost 7,000 of the doses were given using the updated nasal delivery device that Satsuma plans to submit for approval. The most common treatment-related, treatment-emergent adverse events (TEAEs) were nasal discomfort and taste distortion, which respectively affected 11% and 7.6% of subjects. Most, 82.7%, TEAEs were mild.
Satsuma has met the 150-subject exposure-over-time requirement communicated by the FDA, with 166 subjects, on average, treating at least two migraine attacks a month for six months with the updated drug delivery device. On the efficacy front, 34.2% of participants were free from pain two hours after dosing, and 53.4% were free from their most bothersome symptom.
The more conclusive test of the efficacy of STS101 is still to come, with Satsuma expecting to deliver data from the phase 3 trial of its second-generation device in the fourth quarter. If the trial is a success, the company plans to seek FDA approval in the first quarter of next year.