Brexanolone Appears Promising for Treating Postpartum Depression

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 A new intravenous medication—brexanolone—showed promising results in a small, but diverse sample of women with severe postpartum depression, according to a study published online June 12 in The Lancet. Samantha Meltzer-Brody, M.D., says she is encouraged by the results of early clinical trials of brexanolone—an allosteric modulator of both synaptic and extra-synaptic GABA-A receptors—now entering a phase 3 clinical trial.

        “Postpartum depression (PPD) is one of the most common complications of childbirth, but currently there are no treatment options specifically indicated to treat women with PPD,” said Samantha Meltzer-Brody. Because of the serious adverse impact that depression can have on the mother, infant, and family, a medication that acts quickly is important. Psychotherapy and antidepressants can often take weeks to be effective.

             For the double-blind, randomized, controlled trial, researchers assigned 21 women with severe postpartum depression (Hamilton Depression Rating Scale [HAM-D] score of at least 26) to a 60-hour, continuous intravenous dose of brexanolone or placebo. To make the sample as representative as possible, the researchers recruited patients from urban, suburban, and rural settings in the United States to receive treatment at four research sites.By 60 hours, seven (70 percent) women had achieved remission (HAM-D total score of ≤7) compared with one (9 percent) in the placebo group. 

            Brexanolone was found to be generally well tolerated among the study participants. There were no deaths, other serious adverse events, or discontinuations. The most commonly reported adverse events in the brexanolone group were dizziness (two brexanolone-treated subjects; three placebo-treated subjects) and somnolence (two brexanolone-treated subjects; no placebo-treated subjects).

     While these results are encouraging, an ongoing phase 3 clinical program will further evaluate the safety and efficacy of brexanolone. “If successfully developed and approved, this medication would be an enormous step forward for the field,” she said.