The FDA has announced its decision to approve Sage Therapeutics’ intraveneous injection Zulresso (brexanolone), marking the first authorisation of a treatment for postpartum depression (PPD) in adult women in the history of the agency.
The decision was made based on data derived from two trials – one in severe PPD and one in moderate PPD – where patients were monitored for four weeks following a continuous 60-hour infusion of either Zulresso or placebo.
