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US Food and Drug Administration (FDA) Approved drug zuranolone For the treatment of postpartum depressionwhich makes it First FDA-approved oral drug In the U.S. specifically for postpartum depression, a serious mental illness that can occur at about 1 in 7 new mothers postpartum

“this Postpartum depression is a serious and life-threatening condition In such situations, women experience feelings of sadness, guilt, worthlessness and, in severe cases, thoughts of harming themselves or their children. And, because postpartum depression disrupts the mother-infant relationship, it can also have an impact on the child’s physical and emotional development,” said FDA’s Tiffany R. Farchione, MD.

“Able to access Oral medication will be a beneficial option for many of these women They are dealing with extreme, sometimes life-threatening feelings. “

What is postpartum depression?these are the symptoms

FDA adds a box drug label warnings, Noting that it can affect a person’s ability to drive and perform other potentially dangerous activities. Patients may also not be able to assess the extent of their injury.

for reduce the risk of injuryPatients should not drive or operate heavy machinery for at least 12 hours after taking the drug, the agency said.

The most common side effects include Drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis (common cold), and urinary tract infection.

The agency also said that use of the drug cane Lead to suicidal thoughts and behaviors. It may also cause harm to a fetus. Women should use effective birth control while taking the pill and for a week after taking it, the agency said.

this Women with severe postpartum depression may experience suicidal ideation, Maternal suicide deaths account for approximately 20% of all postpartum deaths.

#2 Best Postpartum Depression Drug in the Nation

In February, the manufacturer Biogen Pharmaceuticals and Sage Therapeutics LLC The two companies behind zuranolone announced that the FDA has accepted their zuranolone application for priority review.

“We see The potential of zuranolone, If approved, this would be an important new option that could help address a significant unmet need faced by diverse populations struggling with major and postpartum depression,” said Dr Priya Singhal.

Coping with Postpartum Depression: Diagnosis and Treatment

Treatment options for postpartum depression include counseling or therapy with a mental health professional and antidepressant medications, but at most Zulresso and zuranolone, There are no FDA-approved antidepressants specifically for the treatment of postpartum depression.

besides antidepressants They usually do not provide immediate relief of symptoms and may take several weeks to work.

In 2019, Zulresso becomes first drug to treat postpartum depression for FDA approval.

This treatment is as A single 60-hour IV infusion of the drug brexanolone It has been found to have mild side effects such as headaches, dizziness or excessive drowsiness, and cases of sudden loss of consciousness.

Some Women may face barriers in accessing such treatments, because it takes 60 hours and must be used in a healthcare setting. While zuranolone is a tablet you can take at home.

these two brexanolone is zuranolone They are versions of the naturally occurring substance allopestrol in the body, a neuroactive steroid that is a metabolite of the hormone progesterone.

Tetrahydroprogesterone levels can rise sharply during pregnancy and then drop sharply after delivery, possibly leading to postpartum depression.

so, Restoration of tetrahydroprogesterone with structurally similar drugsDrugs, such as brexanolone or zuranolone, may help relieve symptoms in people with postpartum depression. The two drugs work in a similar way. They are just managed differently.

“After years of dedicated research and collaboration with other scientists across the country, Women with Postpartum and Perinatal Depression “They have a new, easy-to-use at-home treatment option that has the potential to alleviate their symptoms,” said Dr. Kristina Deligiannidis, principal investigator of the national multisite clinical trial that led to the approval in a news release zuranolone.

this Postpartum depression ‘often goes undiagnosed’ Also not getting proper treatment. With today’s FDA decision, we may be able to turn the tide and help more women in need,” Deligiannidis said.

A Phase 3 clinical studies before zuranolone, A 2021 study published in JAMA Psychiatry found that among 151 women with severe postpartum depression, those who took 30 mg of zuranolone daily for two weeks experienced a greater improvement in depressive symptoms compared with those who took a placebo. degree of relief.

Those ones Symptoms lessen within three days and persist for 45 daysThe study was conducted at 27 sites in 2017 and 2018.

A Recent Phase 3 StudyThe study, published last week in the American Journal of Psychiatry, found that the 50 mg dose of zuranolone was well tolerated and effective.

The study found that among 196 women with postpartum depression, Patients who took 50 mg of zuranolone daily for 14 days showed a “significant improvement in depressive symptoms” compared with those who took a placebo.

The day after the women completed the 14-day treatment course, the researchers found 57% said their depressive symptoms improved by 50% or more, This compared with 38 percent of patients who received a placebo.

The researchers followed the women for 45 days and found that 61.9 percent of participants who took zuranolone experienced a significant improvement in symptoms, compared with 54.1 percent of participants who took a placebo.

FDA approves zuranolone trademark “A very important step forward” “In the area of ​​maternal mental health,” Dr. Samantha Meltzer-Brody, who was one of the investigators in the zuranolone clinical trial, said in an email.

How to help someone with postpartum depression?

“This will be an important tool in the treatment of postpartum depression. He Fast-acting antidepressant therapy neededOh, and it would be the first oral formulation of a fast-acting antidepressant. This is important for raising standards and improving treatment options for women with postpartum depression,” Meltzer-Brody said.

“I think many Women will crave a fast-acting antidepressantShe said, adding that if mothers were able to experience relief from postpartum depression within three days, as some participants in the zulanorolone clinical trial found, “that’s extremely important because the postpartum period is a very ‘fragile’ period.” ‘period”.

Some mental health experts raise concerns

The drug’s approval is Major Milestones in Postpartum Depression Treatmentespecially because it has a new biological target and works quickly, says Catherine Monk.

However, he added that there are Some concerns of some maternal mental health experts About zuranolone: ​​The drug was initially tested primarily in women with severe postpartum depression, not mild or moderate depression, and women should still consider psychotherapy as an intervention for depression.

“There are concerns that this drug is for everyone. And for people with mild to moderate depression, the gold standard of treatment is to start psychotherapy and other behavioral and lifestyle changes,” Monk said, adding added Birth control pills should not be the first response of patients with mild to moderate postpartum depression.

“It should be clear that it was initially determined to be effective primarily in people with major depressive disorder,” he said.In addition, there are important Health disparities in postpartum depression rates, the proportion of poor and minority population is much higher. “

While the disparity is a sociopolitical issue, “we have to address it,” Monk said. Social determinants of health in causal pathways of postpartum depression Don’t let the excitement of new drugs overshadow these problems. “

Judit Blanc felt similarly.He said zuranolone is especially beneficial for women Those who face barriers to accessing long-term treatment, such as low-income women or women with limited access to health care.

However, from a scientific, social and ethical perspective, Clinical trials are not a panacea for health crises mothers in America and around the world.

“this Drugs should not be the first or only treatmentor mental health conditions, especially women, children and historically oppressed populations,” she said.

and as an effect zuranolone reported in trial followed for only 45 daysFor postpartum women who are not breastfeeding, Blank added, “More research is needed to assess the long-term effects of zuranolone, including effects in breastfeeding mothers, such as patient-infant interactions.”

this Symptoms of postpartum depression They may include crying, difficulty bonding with your baby, not being able to sleep, or feeling hopeless.

and severe postpartum depressionA woman’s inability to go about her daily life and frequent recurring thoughts of suicide, self-harm, or harming her baby are very serious symptoms that require immediate evaluation and attention.

“Someone has a Really severe depression with frequent suicidal thoughts And a very worrying program,” Monk said.

But she added that for any new mother, “If you feel like you need some support and help, even if you have what we call subclinical depression, it’s okay, reach out, you deserve help, and it probably is. You don’t need as much help as other people with very severe depression, but Let us get the support and help you need, especially before things get worse“.

Information in Spanish from CNN.