US Approves First Pill for Postpartum Depression.

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The Food and Drug Administration (FDA) has granted approval for the first pill to treat postpartum depression (PPD). The pill, known as zuranolone and sold under the brand name Zurzuvae, is a once-daily medication taken for two weeks. Previously, PPD treatment was only available as an intravenous injection. Drug manufacturers Sage Therapeutics and Biogen have announced that the pill is expected to be available later this year, but its price has not been disclosed.

PPD, similar to other forms of depression, may exhibit symptoms such as sadness, loss of energy, suicidal thoughts, decreased ability to feel pleasure, or cognitive impairment, according to the FDA. Research estimates that one in seven women in the US experience symptoms of PPD.

Tiffany Farchione, head of psychiatry in the FDA’s Center for Drug Evaluation and Research, emphasized the seriousness of PPD and its potential life-threatening consequences for women experiencing it. The condition can also affect the maternal-infant bond and have implications for the child’s physical and emotional development.

The availability of an oral medication will be a significant benefit for many women dealing with severe and potentially life-threatening emotions, Farchione added.

Clinical trials demonstrated that the pill substantially reduced depressive symptoms within three days, and its effect was sustained for four weeks after the last dose. The most common side effects of taking Zurzuvae include drowsiness, dizziness, diarrhea, fatigue, the common cold, and urinary tract infection.

However, the labeling contains a boxed warning stating that Zurzuvae may affect a person’s ability to drive and perform other potentially hazardous activities. Patients are advised not to drive or operate heavy machinery for at least 12 hours after taking the medication.

Sage Therapeutics and Biogen sought approval to use zuranolone for major depressive disorder (MDD), but the FDA determined that the medication lacked substantial evidence of effectiveness. Additional studies would be necessary for MDD approval. The companies are currently evaluating their next steps, while emphasizing their disappointment for patients, especially amid the current mental health crisis and the struggles of millions with MDD to find symptom relief.

SOURCE: Ref Image from New Vision

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