Satsuma Pharmaceuticals, which was spun out from SNBL in 2017 specifically for the purpose of developing STS 101 intranasal dihydroergotamine (DHE) for the treatment of migraine, said that a Phase 1 clinical trial demonstrated that STS101 was well tolerated, with none of the typical side effects of injected DHE such as nausea and vomiting. STS101 was rapidly absorbed and reached clinically relevant concentrations within 10 minutes of administration.
The company also said that it had successfully completed a meeting with the FDA regarding its Phase 3 development program for the product and announced plans to begin a Phase 3 study of STS101 in the third quarter of 2019.
Satsuma Chief Medical Officer Detlef Albrecht said, “We are excited to report that the intranasal administration of STS101 in our Phase 1 clinical trial achieved a PK profile that is favorable in comparison with other non-injectable DHE formulations, including liquid nasal spray and pulmonary-route orally inhaled products. The STS101 PK profile is well suited to the treatment of acute migraine and predicts rapid and robust therapeutic effects that may be sustained for 24-48 hours following administration. Completing the STS101 Phase 1 clinical trial brings us one step closer to achieving our goal: making the long-recognized and differentiated therapeutic benefits of DHE broadly available to migraine sufferers in a compact, simple-to-use, self-administered, and non-injectable product.”
Read the Satsuma Pharmaceuticals press release.
