With 1 in 8 women experiencing postpartum depression (PPD), new mothers may experience feelings of hopelessness, withdrawal, and lack of love for their newborn after giving birth.Suicide in America Major Causes of Maternal Death in the first postpartum year.
Despite how common PPD is and the risks it poses, there is only one drug approved for the treatment of PPD, and it must be given as an infusion over 60 hours.known as bLexanoloneApproved by the U.S. Food and Drug Administration (FDA) in 2019, Risk of excessive sleepiness Alternatively, administration may be difficult due to sudden unconsciousness.
That could change on Friday after the FDA approved the first-ever pill for PPD called zranolone.
“Postpartum depression is a serious and potentially life-threatening condition in which women experience feelings of sadness, guilt, and worthlessness, and in severe cases, it can be life-threatening,” said Dr. Tiffany R. Falchione, director of the division. “You may even think about harming yourself or your child.” PhD in Psychiatry from FDA Center for Drug Evaluation and Research press release. “For many women dealing with extreme and sometimes life-threatening emotions, the availability of oral medications could be a beneficial option.”
Zranolone, manufactured by Sage Therapeutics and Biogen and marketed under the brand name Zurzuvae, is to be taken with food for 14 days, according to an FDA press release. Zranolone’s regimen is relatively short-acting and fast-acting, and has been likened to an antibiotic.
“Studies show that only about 10% of women with PPD receive clinically appropriate treatment.”
of clinical research As submitted to the FDA, people who took zranarone Significant improvement in symptoms of depression and anxiety After only 3 days, the effect lasted for a month and a half. The idea is that PPD patients could be given one course of zranarone, after which they could consult with their doctor to decide if they needed another medication or a complementary treatment such as talk therapy, said the study’s lead author. University professor Dr Christina Derjanidis said. Behavioral Sciences Laboratory at The Feinstein Institute for Medical Research, Manhassett, NY.
“Studies have shown that only about 10% of women with PPD receive clinically adequate treatment, which suggests that talking therapy and/or standard-of-care antidepressant medications are appropriate doses. and period,” Derjanidis told Salon in a telephone interview. “The vast majority of women don’t even get our standard of care.”
“It’s reassuring for postpartum women that they may have more options to manage the debilitating condition that affects them and their families.”
Mild cases of PPD have historically been treated with talk therapy, but moderate to severe cases are usually treated with additional antidepressants, especially SSRIs (selective serotonin reuptake inhibitors) such as Zoloft, Prozac, and Lexipro. has been treated with antidepressants of the antidepressant class. But these drugs can take up to 12 weeks to take effect, Dr. Derijannidis said.
She added that many people don’t think it’s practical to spend a few days in the hospital with a broxanalon drip if you have a newborn at home. Some people cannot afford the treatment because the medicine costs about 100 yen. $38,000 per patient. Sage has yet to report how much the new zranolone tablets will cost.
Zranolone belongs to the same drug family as broxanalon, also known by the trade name Zurresso. Both resemble allopregnanolone, a naturally occurring neuroactive steroid that binds to her GABA receptors in the brain. It is believed to work by stabilizing allopregnanolone levels, which fluctuate during and after pregnancy.
Common side effects in studies testing zranarone in women with PPD included drowsiness, dizziness, and fatigue, as well as diarrhea, colds, and urinary tract infections. Because of these side effects, patients are advised not to drive within 12 hours of taking zranarone.
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The FDA also warned that zranalone “may cause fetal harm” because there is not much information about how it is transferred between mother and infant during breastfeeding. In the two main studies that applied for approval, women were advised to stop breastfeeding during childbirth. The treatment period is different. study It was shown that very little drug appeared in breast milk after 5 days of treatment.
sage and biogen Application Zranolone aims to be approved for the treatment of major depressive disorder (MDD), which affects a wider population, but the FDA said the drug company’s application “supports approval of zranolone for depression.” It said it had not provided substantive evidence of efficacy, “a treatment for MDD,” and asked for more data. press release.
The American College of Obstetricians and Gynecologists (ACOG) does not yet have guidance on zranolone, but “addressing mental health issues is of paramount importance to ACOG,” said ACOG Interim CEO and Clinical Practice and Health Equities. Dr. Christopher Zahn, head of sex, said. quality.
“It’s encouraging that postpartum women may have more options to manage the debilitating conditions that affect them and their families,” Zahn added in an emailed statement to the salon.
