Sage Therapeutics has submitted a New Drug Application (NDA) for an intravenous formulation of brexanolone (SAGE-547) for the treatment of postpartum depression (PPD).
Brexanolone is a proprietary allosteric modulator of both synaptic and extrasynaptic GABAA receptors. The NDA is supported by 3 multicenter, randomized, double-blind, placebo-controlled trials (Study 202A, Study 202B, and Study 202C) in women with moderate to severe PPD who were screened ≤6 months after giving birth.
Results in the 202B and 202C trials showed that brexanolone achieved the primary endpoint of mean reduction from baseline in the Hamilton Rating Scale for Depression (HAM-D) compared with placebo at 60 hours (Study 202B: P=.0242 for 90µg/kg/h dose and P=.0011 for 60µg/kg/h dose; Study 202C: P=.0160 for 90µg/kg/h dose). The effect observed at 60 hours in the brexanolone groups was maintained through the 30-day follow-up.
There is currently no FDA approved treatment for PPD. Using the Pregnancy Risk Assessment Monitoring System (PRAMS), the Centers for Disease Control and Prevention (CDC) found that the rate of women who experience PPD is around 1 in 9.
Brexanolone IV received Breakthrough Therapy Designation in 2016.
For more information visit SageRx.com.