- April 24, 2018
- Posted by: PharmaScroll
Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product candidate, an intravenous formulation of brexanolone (SAGE-547), for the treatment of postpartum depression (PPD).
Brexanolone IV received Breakthrough Therapy Designation in September 2016, underscoring the significant unmet need in women with PPD. Breakthrough Therapy Designation is intended to offer a potentially expedited development path and review for promising drug candidates intended to treat serious conditions, including increased interaction and guidance from the FDA.
The NDA submission is supported by data from the Hummingbird Program. This clinical program included three multicenter, randomized, 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.
Brexanolone (SAGE-547) is an allosteric modulator of both synaptic and extrasynaptic GABAA receptors. Allosteric modulation of neurotransmitter receptor activity results in varying degrees of desired activity rather than complete activation or inhibition of the receptor. Sage’s proprietary intravenous (IV) formulation of brexanolone is being developed for the treatment of postpartum depression (PPD) and has been granted Breakthrough Therapy Designation by the FDA and PRIority MEdicines (PRIME) designation from the European Medicines Agency (EMA) in PPD.
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News Source: Sage Therapeutics
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