Sage Therapeutics’ closely watched drug, brexanolone, did not do much better than a placebo in helping patients with a severe type of epilepsy, data from a phase 3 clinical trial show.
Sage, which is based in Cambridge, Mass. expected brexanolone to lead to its first-ever drug approval. Instead, its shares dropped 25 percent to $66 in pre-market trading.
The drug was intended to treat a grave form of uncontrollable epilepsy called super-refractory status epilepticus, or SRSE. A continuous infusion of brexanolone over six days weaned 44 percent of SRSE patients from medically induced comas without seizures returning for 24 hours. The comparable response rate for SRSE patients given a placebo was 42 percent. The small difference favoring brexanolone was not statistically significant, failing the primary endpoint of the 140-patient study, Sage said Tuesday.
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