The FDA Approves New Medicine for Postpartum Depression
Introduction
The Food and Drug Administration (FDA) has granted approval to Sage Therapeutics for a new medicine to treat postpartum depression. This marks the first oral treatment available for the condition. However, the FDA has denied the company’s application for an indication for major depression, which has a much larger potential market.
Rapid-Acting Medicine
The newly approved medicine, sold under the brand name Zurzuvae, is not intended for long-term use. Patients are instructed to take it orally for 14 days. In clinical trials, the drug demonstrated significant improvement in depressive symptoms compared to a placebo. The positive effects were sustained for four weeks after treatment.
Boxed Warning
Zurzuvae’s prescription label includes a boxed warning, which is the FDA’s strongest cautionary statement. The warning highlights the drug’s potential to cause impairment due to sedative effects. Patients taking Zurzuvae are advised not to drive or engage in other potentially hazardous activities until at least 12 hours after dosing during the two-week treatment course.
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– The FDA has approved a new medicine by Sage Therapeutics for postpartum depression.
– The medicine, Zurzuvae, is the first oral treatment for the condition.
– However, the FDA denied the company’s application for an indication for major depression.
– Patients take Zurzuvae orally for 14 days and it significantly improves depressive symptoms.
– The positive effects of Zurzuvae last for four weeks after treatment.
– Zurzuvae carries a boxed warning due to its sedative effects and potential impairment.
– Patients are cautioned not to drive or engage in hazardous activities for at least 12 hours after dosing.
– To read the full article, a subscription to STAT+ is required.
