Neurocrine reports results from SAVITRI, a P-II study (n=183), evaluating safety and efficacy of NBI-1065845 (AMPA) in adults with MDD who had improper response to other MDD treatment
Study met both 1EP and 2EP, showing significant reduction in MADRS score at D28 (Dose 1: -4.3; Other dose: -3) and D56 (Dose 1: -7.5; Other dose: -3.6), respectively.
Common AE observed is headache, no deaths or SAEs; low discontinuation rate. Based on P-II data, company to discuss P-III studies path at FDA meeting
Ref: Neurocrine Biosciences | Image: Neurocrine Biosciences
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