About one in seven women who have a baby experience the black cloud of postpartum depression. More intense and persistent than the "baby blues", the PPD, as we know, can hinder a mother's ability to take care of herself and her new baby, by flooding her with a "sadness to Breathless, "as a mother calls it.
To date, no antidepressant has been specifically designed for these new moms. So many women are prescribed medications approved for the general population. This means that they are not safe or effective and that they do not always work.
On Tuesday, brexanolone was approved by the Food and Drug Administration. Sold under the brand name Zulresso, of Sage Therapeutics, will be the first drug targeting mothers with postpartum depression when it hits the market, probably at the end of June. The drug, administered intravenously by infusion, seems to act much faster than other antidepressants: three days instead of several weeks. Women who received the drug in clinical studies also reported that their mood was better for one month after the infusion.
"Postpartum depression is a serious illness that, when it is serious, can be life threatening. Women may have the idea of hurting themselves or their child, "said Tiffany Farchione, Acting Director of the Division of Psychiatry Products at the FDA's Center for Drug Evaluation and Research. . "This approval … [provides] a new important treatment option. "
But the new drug also requires a lot of women: their time and money. And finally, the costs of brexanolone may be too prohibitive to reach the mothers who would benefit the most.
The drug costs $ 34,000 per patient without insurance, according to Sage Therapeutics. Even if a woman to whom the drug is prescribed can find a way to pay for it, or if her insurance company decides to cover it, she will have to enroll in a hospital or certified clinic to administer the brexanolone and stay connected to an infusion for infusion. 60 hours under medical supervision. Brexanolone also has side effects, including fainting. Women should therefore be constantly accompanied by someone else if they bring their newborns with them.
Nevertheless, for the subgroup of women suffering from very serious postnatal depression, the drug could change the rules of the game, "said Lucy Puryear, medical director of the Texas Children's Center for Reproductive Psychiatry's Pavilion for Houston at Houston, who was not involved in any clinical treatment. drug studies. "These are women who often think about dying," she said. "They can not work, do not get out of bed", explain what we know about brexanolone and why it has met with mixed reactions.
Postpartum depression is very common – but people do not like to talk about it
Postnatal depression is thought to be the most common complication of childbirth, affecting 15% of new mothers shortly before or less than one year after childbirth. Although the disorder may be different from one woman to another, the National Institutes of Health describes the following symptoms: sadness and despair, crying for no reason, anxiety, insufficient sleep or excessive insomnia, and changes in appetite.
However, what sets PPD apart is that new mothers are recovering from an extremely stressful physical event – giving birth to a baby – and suddenly being in charge of taking care of a new life. For example, symptoms of PPD may also include difficulties in bonding with the baby and thinking about harming or harming the baby.
Mothers who experience these feelings do not always want to report them because they may be ashamed or stigmatized. Add to that the fact that access to mental health care in this country is already catastrophic, and this helps to explain why the treatment rate of women with PPD can be so absurdly low: less than 15%.
To date, women with depression during pregnancy or in the ensuing months have access to treatment only for all people with depression – counseling and antidepressants. But drugs have big question marks: patients and doctors have never given clear answers about their effectiveness and safety for mothers because they have not been studied in trials. randomized controlled trials of pregnant or breastfeeding women. And sometimes, antidepressants fail to help women with PDD or help them quickly enough.
Even more frustrating: although PPD is so pervasive – like many women's health issues, doctors still do not know exactly what causes it. Their best hypothesis is that the massive fall of estrogen and progesterone hormones, which occurs after childbirth, triggers changes in brain chemistry. And for some women, it can darken their mood.
"There is a subgroup of women – no one yet understands why – and their brains are sensitive to this drop in hormones that occurs for all women," said Puryear.
How the drug works
The brexanolone developers have decided to tackle this hormonal mechanism of postpartum depression and that is why this drug is unique.
"This is actually what many people think is the trigger for postpartum depression," said Puryear. "This adds to the system a hormone component that may not work well or is not adequate for women with postpartum depression.
Brexanolone has also been tested in women with moderate to severe postpartum depression in several clinical trials. And it seems to take days, not weeks, to work.
In one trial, 21 women with severe PPD were randomly assigned to brexanolone or placebo. Each group assessed its symptoms of depression using the evaluation of clinical trial excellence, called the Hamilton Depression Rating Scale, or HAM-D. On this rating scale, patients are asked about their mood and other symptoms of depression, such as insomnia, agitation, and suicidal ideation. A score of 23 or more is considered a very serious depression.
The women in the brexanolone group had a "significant and clinically significant" reduction in their depression scores compared to women in the placebo group. The drug allowed women to go from a HAM-D score of 28 to 7, which means they went from a state of severe depression to a state of normalcy. In the placebo group, the change was less dramatic: from 29 to 20, depression very serious to severe.
In two other larger trials, published in LancetThe drug again outperformed the placebo after a 60-hour infusion.
Let's remember again that antidepressants can take weeks to work and do not always help women with PPD. The fact that the drug works quickly and appears to reduce the severity of symptoms in women in each trial is remarkable.
Of course, the drug was not without side effects. The most common ones range from flushing and dry mouth to drowsiness and fainting.
These studies were short-term, followed only women for one month. So we do not know how these ratings on a depression scale will translate into women's lives later on. And that's partly why the FDA only approved the drug as part of a restricted program, which means that mothers can not get a prescription from anyone and take it home .
Instead, they should consult a health care provider in a certified clinic to administer brexanolone, and stay at the clinic for two and a half days while the drug is administered by continuous intravenous infusion.
"Because of the risk of serious harm from sudden loss of consciousness, patients should be monitored for excessive sedation and sudden loss of consciousness," the FDA warned. They also need their oxygen levels to be constantly monitored.
If moms decide to have their baby near by during the infusion, they must be accompanied by other people. And the drug could have implications for breastfeeding: Researchers found that brexanolone could pass into breast milk and advised mothers to talk to their doctor if they were breastfeeding.
"This drug adds," said Kimberly Yonkers, a psychiatrist at Yale University, "it's that it's a different mechanism than most drugs that we currently have. " So it may be for people who have not had an adequate reaction to one of the existing drugs. But you have to weigh the benefits of the drug against the costs and the risks.
Sage says that in determining the price of brexanolone, she took into account the fact that postpartum depression represents an unmet medical need and that it is a timely treatment offering rapid relief. Each insurance company will need to determine if the drug is covered.
"It is important to have a drug specifically designed for the treatment of [postpartum] depression, "said Yonkers. "But we are concerned about the mode of administration, it is a heavy burden for patients and our health system. … I think people would be happier if it did not cost $ 34,000. "