Sage Therapeutics: Brexanolone STATUS Trial Fails To Achieve Primary Endpoint

(RTTNews) - Sage Therapeutics (SAGE) reported top-line results from its Phase 3 STATUS Trial of brexanolone (SAGE-547) in the treatment super-refractory status epilepticus. The study did not meet the primary endpoint, comparing success in weaning of third-line agents and resolution of potentially life-threatening status epilepticus with brexanolone vs. placebo when added to standard-of-care. The STATUS Trial was conducted under a Special Protocol Assessment agreement with the FDA and was designed to evaluate the efficacy and safety of brexanolone in patients with super-refractory status epilepticus, ages two years or older, in the U.S., Canada and Europe.

Jeff Jonas, CEO of Sage, said: "Although we did not meet the primary endpoint, this first-ever trial in a highly variable and complex patient population confirms that research in a critical care unit is possible and deepens our understanding of GABA mechanisms and their effect on brain circuitry."