Food and Drug Administration on Friday Approved the first postpartum pill Depression is considered a milestone that is likely to increase awareness and treatment of a debilitating disorder that afflicts about half a million women in the United States each year.
Clinical trial data show that the pill is fast-acting, starting to relieve depression in as little as three days, significantly faster than common antidepressants, which take two weeks or more to take effect. Mothers’ mental health experts said this, and the fact that treatment lasted just two weeks instead of months, could encourage more patients to accept treatment.
Perhaps the most important aspect of this approval is not the drug’s characteristics, but its explicit designation for postpartum depression. Several doctors and other experts believe that while there are other antidepressants that are effective in treating this condition, antidepressants specifically shown to address postpartum depression will become available. , said this has a biological basis, emphasizes what women shouldn’t do, and may help reduce the stigma of postpartum depression. blame yourself.
It is hoped that this will encourage more women to seek help, and more obstetricians and primary care physicians to test symptoms and offer counseling and treatment.
“This patient population often slips through the cracks,” said Ruta Nunux, M.D., a psychiatrist at the Center for Women’s Mental Health at Massachusetts General Hospital. She said, “When a woman is told, ‘You have postpartum depression,’ she is embarrassed, humiliated, and makes her feel like a bad mother.”
She added, “There’s also a lot of stigma around taking antidepressants, which may make this treatment more attractive because it’s actually a treatment specifically for postpartum depression.” added.
An estimated 10 to 15 percent of women who give birth in the United States experience depression during pregnancy or within the first year of pregnancy. This condition may be accompanied by intense anxiety, shame, guilt, sleep disturbances, panic attacks, and suicidal thoughts and attempts. And it can be difficult for mothers to provide their babies with the care, bonding and nurturing that are essential for their healthy development.
“The availability of oral medications will be a beneficial option for many women coping with extreme and sometimes life-threatening emotions,” said the center’s director, Dr. Tiffany R. Falchione. Stated. The FDA division responsible for approval said:statement.
Zranolone, a pill marketed under the brand name Zurzuvae, was developed by Sage Therapeutics, a Massachusetts company that manufactures in partnership with Biogen. Sage said it will be available after the Drug Enforcement Administration completes the 90-day review required for drugs that affect the central nervous system. The companies have not announced prices for the tablets.
The companies had also applied for approval for the drug’s use in a much larger potential market, major depressive disorder. FDA did not issue a decision on that portion of the application. Several psychiatric experts say the data used to treat the disorder are not convincing.
The only drugs approved for postpartum depression are: Brexanolone, also developed by Sage and marketed as Zulresso. But brexanolone, which was approved in 2019, requires a 60-hour intravenous infusion in a hospital, carries the risk of unconsciousness, and costs $34,000. Sage says only about 1,000 patients have received the treatment so far.
Taking the medicine for two weeks is much easier and does not require the mother to leave the baby for several days.However, the FDA has requested that label Include warnings about possible suicidal ideation or behavior, drowsiness or confusion. The label will also include a so-called “black box warning” that patients should not drive or operate heavy machinery for at least 12 hours after taking the tablet. The agency says the tablets should be taken in the evening “with a fatty meal.” announcement Said.
Doctors said Zurzvae isn’t for everyone experiencing postpartum depression. Talk therapy is effective for people with mild to moderate depression. Kimberly Yonkers, M.D., chief of psychiatry at the University of Massachusetts Chang School of Medicine, said she probably wouldn’t recommend the flies for patients with long-standing recurrent depression or those with severe suicide attempts or hospitalizations. Treat for 2 weeks and then discontinue. “
Suitable patients may include “people who have not had a complete response to another antidepressant,” she said.
About 10 percent of patients are likely candidates for it, said Dr. Alison Reminick, director of the Women’s Reproductive Mental Health Program at the University of California, San Diego. This includes women experiencing depression for the first time. Such patients are at high risk of developing bipolar disorder, she said. Drugs such as Lexapro, Zoloft and other selective serotonin reuptake inhibitors (SSRIs) are effective, but can cause mania in these patients, he said.
She also intended to offer Zurzva to depressed women with anxiety and insomnia. That’s because research suggests that zurzva may reduce those symptoms.
“I’m a big fan of SSRIs,” Dr. Reminick says, noting that many patients resist trying them. “I think it would be much easier to just have them try it for two weeks.”
The data submitted to the FDA came from two company-funded clinical trials involving approximately 350 patients. The majority of patients who received Zurzuvae (72% in one trial and 57% in another) clinically responded to treatment after the two-week course, with scores improving by 50% or more on standardized depression scales means that
Depression also improved in women who received the placebo, a common phenomenon in depression treatment research, perhaps because the interaction with the medical team in the trial itself was helpful. However, in the group that received the drizzle, the improvement was consistently several points greater after 3 days of treatment. Fifteen days after taking her first pill, the Zurzvae patient was significantly more likely to have a depression score low enough to be considered in remission.
This effect continued throughout the 45 days monitored in the study, even after patients stopped taking the drug. However, multiple maternal mental health professionals said longer-term data were needed to determine whether patients would relapse.
Drowsiness and dizziness were the main side effects of drowsiness. Study participants showed no evidence of increased suicidal ideation or withdrawal symptoms after stopping the drug.
Amy Bingham, 33, of Gibsonville, North Carolina, received zurzvae in a clinical trial in 2018, about six months after giving birth to her son Benjamin.
Bingham, who works from home at a call center, experienced depression as a teenager, but the symptoms of postpartum depression were different, including panic attacks, tears, and shortness of breath.
“I was so worried that I would do something wrong and that Ben would get hurt because of my mistake,” she said. Then he will be an unhappy baby. “
Sometimes she said, “Sometimes people think I’m a terrible mother because I couldn’t even calm my kids down.”
Data shared with The New York Times said her trial-recorded depression score improved by the third day of taking the medication and reached remission levels by the 15th day.
Under standard procedure for such trials, Bingham couldn’t tell whether the pills he took for two weeks were a dregs fly or a placebo. she said: “At first, I didn’t feel much improvement,” she said.
But over time, she says, “I’m starting to feel better.”
“There are fewer days when I cry like this,” she continued. Ultimately, she felt, she was able to “enjoy spending time with her son.”
Dr. Samantha Meltzer Brody, director of the Center for Female Mood Disorders at the University of North Carolina, says that the flies contain a synthetic version of a neurosteroid or brain hormone called allopregnanolone, which is produced by progesterone and has mood-related effects. It helps regulate neurotransmitters. She is a Ph.D. at Chapel Hill and a principal investigator in the Zurzvae trial for postpartum depression.
During pregnancy, “estrogen and progesterone levels rise manyfold and drop sharply during childbirth,” she says. She added that women who, genetically or otherwise, develop postpartum depression appear to be particularly sensitive to its spikes and dips in which allopregnanolone levels also drop.
Amy Vandenberg, a psychiatric pharmacist at the University of Michigan, said in general, “Increased allopregnanolone helps cope with acute stress.” Zurzvae may address postnatal depression by replenishing allopregnanolone, which is essentially depleted, and targeting the same neurotransmitter to stabilize mood, she said.
Many cases of maternal depression begin during pregnancy, but the pill is not recommended until after childbirth because it affects hormonal pathways and has not been tested in pregnant women, says Meltzer Brody said the doctor. The label warns that this medicine may harm an unborn baby and advises women to avoid pregnancy while taking the pill and for a week after taking it.
This pill was not tested in women breastfeeding babies. Several doctors said they would inform patients considering taking the drug that there was little data on its effects on breastfeeding. Some women may be able to breastfeed for two weeks after they plan to take Zurzvae and then resume breastfeeding. Some of her SSRIs and other antidepressants have been found to be safe for breastfeeding.
About 15 to 20 percent of the women in the trial continued to take other antidepressants they had been taking for some time. Experts said that for some patients, the flies could be used as an adjunct or bridge to long-term antidepressants.
“While it is not the only treatment available for postpartum depression, what is revolutionary and exciting about this treatment is that it is a specific, specific treatment designed to target postpartum depression based on its underlying biological causes. It’s an effective treatment,” said Executive Director Wendy Davis. Postpartum Support International, a non-profit organization that raises awareness and provides resources for those with maternal mental health issues. “It helps you understand that there’s a biological reason for what you’re feeling right now,” she said, adding, “It’s not your fault.”
The fact that there are medications prescribed for the mother’s depression may encourage families to “be aware of it and offer more support to the mother,” Dr. Reminique said.
“If this allows more people to get treatment, that would be great,” Nunax said. “If it doesn’t work, you’re connected to a provider so you can try other things, which opens doors to treatments that were previously hard to open.”
