Sage Says Brexanolone's SRSE Result Doesn't Mean PPD Studies Will Fail
The Phase III study for brexanolone in super-refractory status epilepticus did not meet its primary endpoint, but Sage is optimistic about the drug's prospects in postpartum depression and its earlier-stage SAGE-217.
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The company plans to file an NDA with FDA in the first half of 2018 for an intravenous formulation of brexanolone, which could be the first treatment specifically for postpartum depression.
Highlights from Biomedtracker’s daily reports from the J.P. Morgan Healthcare Conference include products advancing in NASH, competition in CAR-T and more.
Sage Therapeutics is on track to deliver the first ever drug to be indicated for postpartum depression. The company discusses plans for launch and whether or not it wants to partner.