Posted by Michael Wonder on 23 Apr 2018
Sage Therapeutics submits new drug application to U.S. FDA for intravenous brexanolone in the treatment of post-partum depression
23 April 2018 - Brexanolone IV submission is the company’s first new drug application.
Sage Therapeutics today announced the Company has submitted a new drug application to the U.S. FDA for its lead product candidate, an intravenous formulation of brexanolone (SAGE-547), for the treatment of post-partum depression (PPD).
Brexanolone IV received breakthrough therapy designation in September 2016, underscoring the significant unmet need in women with PPD.
The submission is supported by data from the Hummingbird Program. This clinical program included three multi-center, randomised, double-blind, parallel-group, placebo-controlled trials (Study 202A, Study 202B and Study 202C), each designed to evaluate the safety and effectiveness of brexanolone in women with moderate or severe PPD, aged between 18 and 45 years who were ≤6 months postpartum at screening in the United States.
