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Sage Therapeutics Seeks FDA Approval for Brexanolone in Postpartum Depression
The company has previously received breakthrough therapy designation for the treatment.
Sage Therapeutics today submitted a new drug application (NDA) to the FDA for intravenous brexanolone, which has already received breakthrough therapy designation for the treatment of postpartum depression (PPD). The company announced the filing in a statement.
Brexaolone IV, the company’s first NDA, has succeeded in 2 phase 3 trials at beating placebo in reducing patients’ symptoms of PPD, a condition that affects an average of 11.5% of new mothers each year. The intravenous form of the drug requires a 60-hour infusion. Sage Therapeutics is also developing a pill form of the drug.
The drug is an allosteric modulator of both synaptic and extrasynaptic GABAA receptors, proteins that were revealed as the potential target of a PPD treatment a decade ago in experiments with mice at the University of California Los Angeles. These preclinical experiments showed that the GABAA fell during pregnancy to keep the body in sync with neurosteroid levels, and then rose after birth. But if dysregulation occurs, the depression ensues.
PPD can cause significant functional impairment for women and their families, and the condition can include lack of interest in the newborn, loss of appetite, difficulty sleeping, and lack of concentration. Right now, there are no FDA-approved therapies for the condition and significant unmet need.
Examining Low-Value Cancer Care Trends Amidst the COVID-19 Pandemic
April 25th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the April 2024 issue of The American Journal of Managed Care® about their findings on the rates of low-value cancer care services throughout the COVID-19 pandemic.
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Empowering Community Health Through Wellness and Faith
April 23rd 2024To help celebrate and recognize National Minority Health Month, we are bringing you a special month-long podcast series with our Strategic Alliance Partner, UPMC Health Plan. In the third episode, Camille Clarke-Smith, EdD, MS, CHES, CPT, discusses approaching community health holistically through spiritual and community engagement.
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What We’re Reading: FDA Approves UTI Antibiotic; Ozempic, Wegovy Price Investigation; US Births Fall
April 25th 2024The FDA recently approved an antibiotic for the treatment of urinary tract infections (UTIs) in women; a Senate committee recently launched an investigation into the prices of Novo Nordisk’s diabetes and weight loss drugs; US births fell last year, resuming a national slide after a previous increase during the pandemic.
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HOPE-CAT Can Identify Maternal Cardiovascular Risk 2 Months Earlier Than Doctors, Study Says
April 25th 2024In a retrospective study, the machine learning tool was able to screen for potential risks of cardiovascular disease nearly 60 days before the patient's medical record showed any signs of a related condition or before they were officially diagnosed or treated for it.
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