The company has previously received breakthrough therapy designation for the treatment.
Sage Therapeutics today submitted a new drug application (NDA) to the FDA for intravenous brexanolone, which has already received breakthrough therapy designation for the treatment of postpartum depression (PPD). The company announced the filing in a statement.
Brexaolone IV, the company’s first NDA, has succeeded in 2 phase 3 trials at beating placebo in reducing patients’ symptoms of PPD, a condition that affects an average of 11.5% of new mothers each year. The intravenous form of the drug requires a 60-hour infusion. Sage Therapeutics is also developing a pill form of the drug.
The drug is an allosteric modulator of both synaptic and extrasynaptic GABAA receptors, proteins that were revealed as the potential target of a PPD treatment a decade ago in experiments with mice at the University of California Los Angeles. These preclinical experiments showed that the GABAA fell during pregnancy to keep the body in sync with neurosteroid levels, and then rose after birth. But if dysregulation occurs, the depression ensues.
PPD can cause significant functional impairment for women and their families, and the condition can include lack of interest in the newborn, loss of appetite, difficulty sleeping, and lack of concentration. Right now, there are no FDA-approved therapies for the condition and significant unmet need.