Sage Therapeutics Files NDA for Brexanolone in Postpartum Depression Treatment
Brexanolone received breakthrough therapy designation in September 2016, underscoring the significant unmet need in women suffering from postpartum depression.
Sage Therapeutics has announced the submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for an intravenous formulation of SAGE-547 (brexanolone IV) for the treatment of women with moderate or severe postpartum depression.
The NDA submission is backed by data from the Hummingbird Program which included 3 multicenter, randomized, double-blind, parallel-group, placebo-controlled trials (Study 202A, Study 202B and Study 202C) all designed to evaluate the safety and effectiveness of brexanolone in women with moderate or severe, ages 18—45 years old who were ≤6 months postpartum at screening in the US.
Entry criteria for participants included depressed mood and/or loss of interest in associated symptoms of depression, including appetite problems, sleep problems, motor problems, lack of concentration, loss of energy, poor self-esteem and suicidality beginning no earlier than the third trimester and no later than the first 4 weeks following delivery.
Positive top-line results from 2 trials were announced in November 2017.
In Study 202B in severe postpartum depression and Study 202C in moderate postpartum depression, brexanolone achieved the primary endpoint which included a mean reduction from baseline in the Hamilton Rating scale for Depression total score versus placebo at 60 hours (Study 202B: p=0.0242 for 90 µg/kg/h dose and p=0.0011 for 60 µg/kg/h dose; Study 202C: p=0.0160 for 90 µg/kg/h dose).
Brexanolone-treated patients experienced mean reductions from baseline in Hamilton Rating scale for Depression total scores of 14 to 20 points at 60 hours, maintained to 30 days in both trials.
The drug was generally well tolerated and showed a similar safety profile as seen in earlier studies.
Brexanolone is an allosteric modulator of both synaptic and extrasynaptic GABAA receptors and has been granted Breakthrough Therapy designation by the FDA in September 2016 and Priority Medicines (PRIME) designation from the European Medicines Agency (EMA), underscoring the significant unmet need in women suffering from postpartum depression.
