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The FDA approved zuranolone (Zurzuvae) as the first oral treatment for postpartum depression, the late on Friday.

Until now, brexanolone (Zulresso) has been the only other treatment with an indication for postpartum depression, but that drug requires a continuous IV infusion administered by a healthcare provider.

"Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness -- even, in severe cases, thoughts of harming themselves or their child. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child's physical and emotional development," Tiffany R. Farchione, MD, director of the Division of Psychiatry at the FDA's Center for Drug Evaluation and Research, said in a statement.

"Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings," she added.

Underpinning zuranolone's approval were two phase III trials in the NEST clinical program. Trial participants included women with postpartum depression who met DSM-5 criteria for a major depressive episode with symptom-onset in the third trimester or within 4 weeks of delivery.

Both studies met their primary endpoint, with zuranolone leading to significantly greater drops of 4.0 to 4.2 points on the 17-item Hamilton depression rating scale (HAMD-17) total score at day 15 compared with placebo.

In one of the two trials, women on zuranolone were more than twice as likely to experience remission of symptoms at the end of the 2-week treatment course, and the difference between arms was maintained out to day 45. Symptom improvement was seen as early as day 3 of treatment, and zuranolone-treated patients also experienced improvement in anxiety symptoms.

The most common side effects in trials (occurring in 5% or more of patients) were drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection. Zuranolone also may cause suicidal thoughts or behavior, the FDA noted.

A neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator, zuranolone is given at a 50-mg dose in the evening with fat-containing food over a 14-day course, either alone or as adjunct to an oral antidepressant. Doses of 30 mg are recommended for patients with severe hepatic impairment or moderate to severe renal impairment.

The dose should also be dropped down to 40 mg if patients experience central nervous system (CNS) depressant effects, and for the drug carries a boxed warning stating that zuranolone can cause driving impairment due to these CNS depressant effects. Patients are advised not to drive or operate heavy machinery for at least 12 hours after taking the treatment.

Women on therapy are also recommended to use contraception during treatment and for a week after since zuranolone may cause fetal harm. The label also notes that the controlled substance schedule is pending.

In contrast to the postpartum depression approval, the FDA rejected zuranolone for major depressive disorder (MDD) in adults, .

In its complete response letter, the agency said there was not substantial evidence of effectiveness to support approval for the MDD indication and called for additional studies, according to the two companies. The MDD application included data from the phase III LANDSCAPE clinical program, including the WATERFALL and SHORELINE studies.

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