{"id":397705,"date":"2023-08-06T22:55:00","date_gmt":"2023-08-06T22:55:00","guid":{"rendered":"https:\/\/www.saipantribune.com\/?p=397705"},"modified":"-0001-11-30T00:00:00","modified_gmt":"-0001-11-29T14:00:00","slug":"FDA-approves-pill-to-treat-postpartum-depression","status":"publish","type":"post","link":"https:\/\/www.saipantribune.com\/index.php\/FDA-approves-pill-to-treat-postpartum-depression\/","title":{"rendered":"FDA approves pill to treat postpartum depression"},"content":{"rendered":"

A fast-acting depression pill from Biogen Inc. and Sage Therapeutics Inc., the first specifically intended to treat postpartum depression, was cleared for the market by U.S. regulators.<\/p>\n

The drug, which will be sold as Zurzuvae, is designed to help people feel better in a matter of days, instead of weeks like most commonly used antidepressants. It\u2019s meant to be taken for only two weeks. The FDA approved the drug, granting the application priority review and fast track designation.<\/p>\n

\u201cPostpartum depression is a serious and potentially life-threatening condition,\u201d said Tiffany R. Farchione, director of the Division of Psychiatry in the FDA\u2019s Center for Drug Evaluation and Research. \u201cHaving access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.\u201d<\/p>\n

The partners see a big opportunity. An estimated 21 million adults in the U.S. experienced at least one major depressive episode in 2020, according to a National Institutes of Health estimate. About one in eight new mothers experiences postpartum depression, according to the Centers for Disease Control and Prevention.<\/p>\n

Zurzuvae, a daily pill, helped people feel better within days in clinical trials. However, the drug has faced questions about whether the improvement lasts once people stop taking it. That could limit interest from doctors and insurers, especially with cheap generic drugs so embedded into the current treatment.<\/p>\n

Biogen and Sage will also need to raise awareness of postpartum depression. Although it\u2019s common, one study found only about half of women with the condition are diagnosed and only about 10% are adequately treated. Sage sells an infused drug similar to Zurzuvae that\u2019s struggled to gain traction.<\/p>\n

Kristina Deligiannidis, a principal investigator on Zurzuvae\u2019s postpartum depression clinical trials, thinks this time will be different since women will be more interested in taking a pill every day for two weeks rather than sitting through a nearly three-day infusion.<\/p>\n

\u201cThis is really going to change the way we treat postpartum depression,\u201d said Deligiannidis, director of women\u2019s behavioral health at Northwell Health\u2019s Zucker Hillside Hospital.<\/p>\n

It\u2019s possible Zurzuvae will be used to kickstart treatment and then be augmented with traditional antidepressants to ensure relief, said Samantha Meltzer-Brody, director of the University of North Carolina\u2019s Center for Women\u2019s Mood Disorders. Women in the postpartum trials continued feeling better for 45 days, but they weren\u2019t tracked beyond that, so doctors may want the security of a treatment that\u2019s known to work long-term, said Meltzer-Brody.<\/p>\n

Before Biogen and Sage can start selling Zurzuvae, they\u2019ll need clearance from the Drug Enforcement Administration, which categorizes certain drugs based on their potential for abuse. The companies anticipate that will happen about three months after approval.<\/p>\n

Analysts expect sales of about $1 billion for Sage by 2029 and $1.2 billion for Biogen, which will receive half of U.S. profits and has the rights to sell the drug in most international markets.<\/p>\n

<\/p>\n

A fast-acting depression pill from Biogen Inc. and Sage Therapeutics Inc., the first specifically intended to treat postpartum depression, was cleared for the market by U.S. regulators.<\/p>\n

-Dreamstime
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