FDA approves drug zuranolone/Internet
The U.S. Food and Drug Administration (FDA) has approved zuranolone, the first specific oral drug for the treatment of postpartum depression (PPD), a disorder that affects some women before and after childbirth.
It is estimated that about one in eight mothers experience postpartum depression, making it one of the most common complications during and after pregnancy.
New, more convenient treatment options
The disorder is usually treated with talk therapy and medications such as antidepressants, primarily selective serotonin reuptake inhibitors (SSRIs). However, these drugs often take a while to work in patients.
Zuranolone: ​​DPP Oral
Until now, treatment for PPD has only been given intravenously. However, the FDA has approved the new drug to be taken once daily for two weeks and then discontinued.
Coming Soon as Zurzuvae
It is expected to be available in the United States later this year under the brand name Zurzuvae. The drug is being developed by US laboratory Sage Therapeutics in association with Biogen, according to The New York Times.
Zuranolone and its mechanism of action
Zuranolone is a neuroactive steroid related to tetrahydroprogesterone. Its presence in the body increases during childbirth but decreases dramatically after birth. This drug belongs to a class of drugs called neuroactive steroids, which act on the brain, specifically the GABA-A receptors.
Clinical study yields promising results
Clinical studies have shown that the pill helps to significantly reduce symptoms of depression in just three days. However, the FDA warns that the drug may cause side effects such as drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis (common cold) and urinary tract infections. Additionally, it has been noted that it can induce suicidal thoughts and behaviors.
Precautions and suggestions for use
The agency also recommends that patients should not drive a vehicle for at least 12 hours after taking the drug. A dose of 50 mg is recommended to be taken once daily for 14 days, in the evening with a fatty meal. Likewise, the importance of using effective contraception while taking the pill and for a week after the end of treatment was emphasized.
Benefits for women with postpartum depression
“For many women who are dealing with extreme and sometimes life-threatening sensations, access to oral medications would be beneficial,” added Tiffany R. Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, in an official statement.
/ World Medical Center