only new drugs Approved by the U.S. Food and Drug Administration Could revolutionize treatment of postpartum depression 1 in 8 women who have recently given birth are affected.
The drug zranolone, marketed under the brand name Zurzuvae, is the first oral drug approved by the FDA for the treatment of postpartum depression, the depression that occurs after childbirth.
“Postpartum depression is a serious, potentially life-threatening condition in which women experience feelings of sadness, guilt, worthlessness, and, in severe cases, thoughts of harming themselves or their children. And since postpartum depression can disrupt the mother-child bond, it can also affect a child’s physical and emotional development,” said the FDA Center for Drug Evaluation and Research. Dr. Tiffany R. Falchione, Director of Psychiatry, said. in the statement. “For many women dealing with extreme and sometimes life-threatening emotions, the availability of oral medications could be a beneficial option.”
Symptoms of postpartum depression include separation from loved ones, crying more than usual, feeling anxious or overly anxious, feeling angry, doubting one’s ability to care for the baby, and worrying about harming oneself or the baby. It includes such things as thinking about it. U.S. Centers for Disease Control and Prevention. These symptoms can last for weeks or months after giving birth and are more intense and last longer than the “baby blues” that women experience after giving birth.
A history of depression may increase the risk of postpartum depression, but there is no single test that can diagnose postpartum depression or predict whether a woman will suffer from postpartum depression. When difficulties arise after childbirth, it is often up to a woman, her partner, or her family to seek professional medical help.
Here are five things you should know about this new drug.
1. Zurzvae is a daily medicine
Fast-acting antidepressants are designed to be taken once daily for 14 days. The recommended daily dose is 50 milligrams, and users are advised to take the drug in the evening with a fatty meal, according to the FDA.
The FDA warns that users of the flies should not “drive or operate heavy machinery” for at least 12 hours after taking the drug.
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Additionally, the FDA says that women should “use effective contraception during and for one week after taking the flies,” because the flies can harm an unborn baby.
2. Zurzuvae should be available this year
Drift fly is a drug that affects the central nervous system, so it will undergo a 90-day review by the Drug Enforcement Administration as per normal procedures.
The drug will then be available to consumers later this year.
Zurzuvae’s makers, Sage Therapeutics and Biogen, have not yet announced pricing for the drug.
3. The drug has shown promising clinical results
Zurzuvae’s success has been documented in two clinical studies, according to the FDA.
Phase 3 trial It was published last month in the American Journal of Psychiatry. Zurzuvae found that it “demonstrated significant improvement in depressive symptoms and was generally well tolerated.”
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The trial, which included about 200 patients, found that those who took the dregs reported “significant improvements in their depressive symptoms” within 45 days of treatment.
An early study, published in 2021, found that after two weeks of daily treatment with zranolone, women treated with the drug “compared to women who received a placebo had a core depression A statistically significant reduction in symptoms was found.”
According to a study published in , after 45 days, 53% of women who received zranolone were in complete remission of their clinical depression, compared to 30% of women who received a placebo. American Medical Association Journal of Psychiatry.
4. There is only one other postpartum medicine available to the mother
Currently, there is only one FDA-approved over-the-counter drug for the treatment of postpartum depression. The drug, called Zlesso, is available as a single 60-hour infusion and can cost as much as $20,000 to $35,000 per treatment.
Treatment is recommended as a non-pharmacological treatment for postpartum depression.
5. Drifts help regulate brain function
Zurzuvae addresses postpartum depression by helping rebalance neuronal networks for healthy brain function.
According to Biogen, zranolone, marketed as Zurzuvae, is an “oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). The GABA system regulates major inhibitory signals in the brain and central nervous system. It’s a pathway that regulates brain function.”
Dr. Darien Sutton, an emergency medicine physician and ABC News medical contributor, said the FDA’s approval of zurzvae shows that postpartum depression is a serious medical problem.
“Having this drug labeled specifically for postpartum depression helps us recognize that this is due to a biological problem and not the result of a moral failure,” Sutton said in “Good Morning America. ‘ said. “This is a reminder to all of us that there is a National Suicide Lifeline at 988, whether or not anyone is struggling with self-harm or suicidal thoughts at home. If you need help, You can call or send a text message.”
Regarding postpartum depression in particular, Dr. Sutton added, “Don’t get me wrong, this diagnosis can be life-threatening and if a mother has symptoms, it’s important to seek help and attention as soon as possible.” .
For families dealing with postpartum depression, Postpartum Support International offers a free and confidential phone and text helpline at 1-800-944-4PPD (4773). If you or someone you know is struggling with suicidal thoughts, call or text 988 or chat at 988lifeline.org. Free, confidential support is available 24/7. You are not alone.
