Shots:
- The US FDA has approved 505(b)(2) NDA of Atzumi (STS101) nasal powder for the acute treatment of migraine with or without aura in adults
- Approval was based on a P-I PK trial & P-III (ASCEND) trial, both showing fast absorption, rapid high DHE levels, & sustained DHE plasma concentrations over time
- Atzumi utilizes SMART (Simple MucoAdhesive Release Tech) platform to integrate Satsuma’s proprietary DHE nasal powder & unique delivery device for portable & easy-to-use migraine treatment
Ref: Prnewswire | Image: Satsuma Pharmaceuticals
Related News:- Johnson & Johnson Reports the US FDA’s Approval of Imaavy (Nipocalimab-aahu) for Generalized Myasthenia Gravis (gMG)
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