October 3, 2023

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FDA approves first oral drug for postpartum depression

FDA approves first oral drug for postpartum depression


FDA approves first oral drug for postpartum depression. Over 400,000 new mothers suffer from depression each year.

According to the National Institutes of Health (NIH), about one in seven new mothers may experience depression after giving birth.

On August 4, the FDA approved the first oral drug for the treatment of postpartum depression. Postpartum depression is a serious mental illness that affects about one in seven new mothers after giving birth, according to the National Institutes of Health (NIH).

The latest approval, called zuranolone, was developed by Biogen and Sage Therapeutics and is taken once daily by patients for 14 days.


FDA approves first oral drug for postpartum depression



A 50 mg dose of zuranolone was well tolerated and effective, according to a new phase 3 clinical study published last week in the American Journal of Psychiatry.

In a study of 196 women with postpartum depression, those who took 50 mg zuranolone daily for 14 days showed a significant improvement in depressive symptoms of more than 50% compared to those who took a placebo 38% of symptoms improved.


The treatment of postpartum depression requires a fast-acting antidepressant therapy.

The industry believes that zuranolone will be the first oral drug preparation for postpartum depression, which will help to help puerpera quickly get out of the haze of mental illness.


“Postpartum depression is a serious and potentially life-threatening disorder in which women experience feelings of sadness, guilt, worthlessness and, in severe cases, thoughts of harming themselves or their children.” U.S. FDA Center for Drug Evaluation and Research, Division of Psychiatry Director Tiffany Farchione said, “Because postpartum depression can disrupt the mother-infant relationship and have an impact on the child’s physical and emotional development, access to oral medications would be a benefit for women dealing with extreme and sometimes life-threatening feelings. s Choice.”


Zuranolone’s approval followed in 2019 when brexanolone, an intravenous antidepressant, became the first FDA-approved drug for postpartum depression.

The therapy uses a single 60-hour intravenous infusion, and long-term treatment leads to poor compliance of patients.


From the perspective of drug mechanism, brexanolone and the latest approved zuranolone are allopregnanolone (tetrahydroprogesterone), a neuroactive steroid naturally occurring in the human body.

This substance is a metabolite of the hormone progesterone. The level of tetrahydroprogesterone is between A sharp rise during pregnancy followed by a sudden drop after delivery may be a contributing factor to postpartum depression.


Therefore, restoring tetrahydroprogesterone levels with a structurally similar drug could help relieve symptoms in patients with postpartum depression.


Chen Jun, chief physician of the Shanghai Mental Health Center, told Yicai.com: “At present, no postpartum antidepressant drugs have been approved for marketing in China. The treatment for postpartum depression is similar to that for the general population, but changes in female hormones and Breastfeeding problems.”


Women with severe postpartum depression who are unable to go about their daily lives and often have recurring thoughts of suicide, self-harm, or harming their baby are very serious symptoms that require immediate evaluation and attention.

However, in reality, clinical attention to postpartum depression is still insufficient.


It is estimated that more than 400,000 mothers of babies in the U.S. suffer from depression each year, and without any treatment, postpartum depression can linger for months or even years, according to the National Institute of Mental Health.

Statistics show that maternal deaths caused by suicide in the United States account for about 20% of the total number of postpartum deaths.


However, the FDA warns on the drug’s label that taking the drug may affect a person’s ability to drive and perform other potentially dangerous activities, so patients should not drive or operate heavy machinery for at least 12 hours after taking the drug.

The drug’s most common side effects also included drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection.


Some experts also emphasized that this new type of antidepressant drug should be used in women with severe postpartum depression.

For mild or toxic depression, patients should still consider psychotherapy as an intervention for depression.


In addition, because the reported effects of Zuranolone in clinical trials were only followed for 45 days in non-breastfeeding postpartum women, experts suggest that further studies are still needed to assess the long-term effects of Zuranolone, including in breastfeeding mothers .




FDA approves first oral drug for postpartum depression

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