Drugs@FDA: FDA Approved Drug Products: very technical language heavy, viewable history, letters, labels from Sage Therapeutics. Note a study is coming available for 15-18 year olds; underage mothers are at a significantly higher risk for perinatal mental health complications.
Your deferred pediatric study required by section 505B(a) of the Federal Food, Drug, and Cosmetic Act (FDCA) is a required postmarketing study. The status of this postmarketing study must be reported annually according to 21 CFR 314.81 and section 505B(a)(4)(C) of the FDCA.
This required study is listed below.
3535-1 Conduct a randomized, double-blind, placebo-controlled, parallel-group study evaluating efficacy and safety of brexanolone in adolescent females, 15 years to less than 18 years of age, diagnosed with postpartum depression.
Final Protocol Submission: 01/2018https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211371Orig1s000ltr.pdf
Study/Trial Completion: 10/2020
Final Report Submission: 04/2021
Postpartum depression is the most common medical complication of childbirth, estimated to affect 8-20% of new mothers in the U.S., varying by state with an overall average of 11.5%.1-5 During pregnancy, levels of certain hormones rise and then rapidly fall after giving birth. These hormone shifts may put some women at risk for developing this serious disorder.https://www.sagerx.com/programs-research/psychiatric-disorders/
Postpartum depression can have devastating consequences for a woman and for her family, which may include significant functional impairment, depressed mood and/or loss of interest in her newborn, and associated symptoms of depression such as loss of appetite, difficulty sleeping, worry or feeling overly anxious, motor challenges, lack of concentration, loss of energy and poor self-esteem.
Sage’s lead product, designated by FDA as a breakthrough therapy for the treatment of postpartum depression, was recently approved by the FDA pending DEA scheduling. We are also developing another product candidate, SAGE-217, in the treatment of postpartum depression as part of a broader depression program.