The FDA, which expected to approve or deny Sage Therapeutics’ brexanolone next month, has pushed that decision off to March 19. The three-month delay will allow the agency to work on risk evaluation and mitigation strategies (REMS) to improve the treatment’s safety. It did not ask Sage for additional data or information.
The delay comes two weeks after an advisory committee overwhelmingly backed the approval of brexanolone injection for the treatment of postpartum depression. The drug is an analog of the human hormone allopregnanolone. It is unclear how, exactly, it treats postpartum depression, but it appears to be a “positive allosteric modulator of GABAA receptors with a binding site distinct from benzodiazepines,” a class of psychoactive drugs used to treat conditions such as panic attacks, insomnia, seizures and alcohol withdrawal. It is given to patients in a 60-hour intravenous infusion, requiring both patients and providers to commit to long in-clinic infusions.
In a pair of phase 3 trials, brexanolone achieved its primary endpoint of change in Hamilton Rating Scale for Depression from baseline. However, the FDA pointed out a major safety concern in briefing documents—loss of consciousness during infusion—that it thought could not be solved with labeling alone. It recommended the use of REMS to address the issue.
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All of the advisory committee members but one were satisfied with this recommendation.
“I struggled because of the idea of crossing my fingers and hoping it gets done that way,” said Kim Witczak, the committee’s designated consumer representative.
Sage submitted a REMS program to the FDA after the advisory committee meeting.
“Our primary goal remains bringing treatment to women suffering from PPD as quickly as possible. In light of this unexpected delay, we will work diligently with the FDA to ensure that the unmet medical need of women suffering with PPD can be addressed expeditiously,” said Sage CEO Jeff Jonas, M.D., in a statement.
If approved, brexanolone would be the first treatment approved specifically for postpartum depression. The disorder is currently treated with talk therapy, counseling and/or antidepressants, which, according to the FDA, “show little evidence” of efficacy in postpartum depression.