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(Correcting the name of Sage Therapeutics Inc. Please ignore incorrect coding of Shield Therapeutics PLC.)
(Alliance News) - The US Food & Drug Administration has approved Zurzuvae, zuranolone, 50 mg for adults with postpartum depression, Sage Therapeutics Inc and Biogen Inc said in a statement.
Zurzuvae is the first and only oral, once-daily, 14-day treatment that can provide rapid improvements in depressive symptoms for women with postpartum depression, the companies said.
Until now, treatment for postpartum depression was only available as an IV injection given by a health care provider in certain health care facilities.
Postpartum depression is a major depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy.
According to the companies, Zurzuvae is expected to launch and be commercially available in the fourth quarter of 2023 shortly following scheduling as a controlled substance by the US Drug Enforcement Administration, which is anticipated to occur within 90 days.
The labeling contains a boxed warning noting that Zurzuvae can impact a person's ability to drive and perform other potentially hazardous activities. Patients also may not be able to assess their degree of impairment.
To reduce the risk of harm, patients should not drive or operate heavy machinery for at least 12 hours after taking Zurzuvae.
Meanwhile, Sage Therapeutics and Biogen said that the FDA issued a complete response letter for the new drug application for zuranolone in the treatment of adults with major depressive disorder.
The letter stated that the application did not provide substantial evidence of effectiveness to support the approval of zuranolone for the treatment of major depressive disorder and that an additional study or studies are needed.
source: dpa
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