FDA Approves Drug for Treating Postpartum Depression - NBC 10 Philadelphia
National & International News
The day’s top national and international news

FDA Approves Drug for Treating Postpartum Depression

The agency on Tuesday approved Sage Therapeutics' Zulresso

    processing...

    NEWSLETTERS

    FDA Approves Postpartum Drug

    The Food and Drug Administration has approved the first-ever drug, developed in Cambridge, to treat postpartum depression.

    (Published Tuesday, March 19, 2019)

    The U.S. Food and Drug Administration has approved the first drug specifically developed for severe depression after childbirth.

    The agency on Tuesday approved Sage Therapeutics' Zulresso, an IV drug given over 2 ½ days.

    Sage said Zulresso will cost $34,000 without insurance, plus costs for staying in a hospital or infusion center. Whether the treatment gets covered by insurance is determined by each insurance company, which also sets the out-of-pocket costs, depending on the plan.

    In a company-funded study of new mothers with moderate or severe postpartum depression, half the women given Zulresso had depression end within 2 ½ days, about double the rate of those in a comparison group given dummy treatments.

    Mueller Report: 10 Instances of Possible Obstruction of Justice by Trump

    [NATL] Mueller Report: 10 Instances of Possible Obstruction of Justice by Trump

    Special counsel Robert Mueller's report on Russian interference in the 2016 presidential election included instances of potential obstruction by President Donald Trump. Here is a rundown of the ten mentioned in the report.

    (Published Thursday, April 18, 2019)

    Postpartum depression affects about 400,000 American women a year. It often ends on its own within a couple weeks, but it can continue for months or even years. It can be treated with antidepressants, which can take six to eight weeks to work and don't help everyone, or with counseling.

    "Postpartum depression is a serious condition that, when severe, can be life-threatening," Dr. Tiffany Farchione of FDA's Division of Psychiatry Products said in a statement. "Women may experience thoughts about harming themselves or harming their child,"

    Zulresso's active ingredient, brexanolone, mimics a derivative of the naturally occurring hormone progesterone, levels of which can plunge after childbirth. The infusion helps restore normal levels and emotions, according to Sage Chief Executive Dr. Jeff Jonas.

    The drug's most common side effects were sleepiness, dizziness and headaches. A few women had more-serious problems, such as fainting and loss of consciousness.

    Because those risks could result in injury, the FDA said it is restricting Zulresso's use to certified health care facilities where patients can be closely monitored throughout the infusion.

    Zulresso appears safe for breastfeeding, said Dr. Kimberly Yonkers, a psychiatrist specializing in postpartum depression who heads Yale Medical School's Center for Wellbeing of Women and Mothers.

    Trump Celebrates Mueller Report as Democrats Plan Next Step

    [NATL] Trump Celebrates Mueller Report as Democrat Lawmakers Plan Next Step

    President Donald Trump celebrated the release of Special Counsel Robert Mueller's report into Russia collusion today, but Democrats say this story isn't over and are already talking about their next step. The report, which totals over 400 pages, neither condemns nor exonerates the president.

    (Published Thursday, April 18, 2019)

    She expects the drug will be used to treat serious cases and patients not helped by antidepressants.

    "It's going to depend on patient willingness to go into an infusion center and insurers being willing to pay for this," Yonkers added.

    Sage plans to begin selling the drug in late June.

    It's developing a second, similar treatment in pill form, and Marinus Pharmaceuticals is testing both a pill and IV therapy.