Industry Briefs

Sage Therapeutics last week announced positive top-line results from two phase 3 clinical trials of its intravenous drug brexanolone for the treatment of postpartum depression (PPD). Participants in both studies—one for moderate PPD and one for severe PPD—showed statistically significant mean reduction from baseline in the Hamilton Rating Scale for Depression (HAM-D) following a 60-hour infusion of brexanolone compared with a placebo infusion. The improvements in depression scores were maintained 30 days later.

Brexanolone, which modulates GABA receptor activity, was generally well tolerated in both studies with similar rates of adverse events across all treatment groups. The most common adverse events reported were headache, dizziness, and somnolence. There was one participant in each trial who experienced a serious adverse event, but neither required hospitalization. As of press time, Sage had not responded to a request by Psychiatric News for more information on the nature of these adverse events.

A press release from the company stated the following: “Sage believes these data will be sufficient to support submissions of regulatory applications seeking approval of brexanolone for PPD.” The company plans to file a New Drug Application with the Food and Drug Administration in 2018, the release noted.

Fresenius Kabi USA is voluntarily recalling Lot 6400048 of midazolam, 2 mg/2 mL packaged in a 2-mL prefilled single-use glass syringes. Midazolam is indicated for sedation, anxiety, and for induction of general anesthesia. The lot was recalled because the package incorrectly contained syringes containing 4 mg/2mL of the anti-nausea medication ondansetron.

The affected lot expires July 2018. Fresenius Kabi is notifying its distributors and customers by letter and is arranging for return of the recalled product. ■