The Food and Drug Administration has approved the first-ever pill to treat postpartum depression (PPD), which affects about one in seven new mothers.
Zuranolone, an antidepressant, is a pill that is taken once a day and taken for two weeks. It will be sold under the brand name Zurzuvae.
Clinical trials showed that it improved the symptoms of new mothers who experienced major depression after having a baby.
The only other drug on the market for PPD, Zulresso, must be given continuously by IV for 60 hours and costs $34,000.
Symptoms of PPD can be debilitating and range from deep despair and frequent crying to thoughts of hurting the baby, feeling disconnected from the child, or feeling like it belongs to someone else.
The Food and Drug Administration has approved the first-ever pill to treat postpartum depression (PPD), which affects about one in seven new mothers
Zuranolone, an antidepressant, is a once-daily pill to be taken for two weeks. It will be sold under the brand name Zurzuvae
PPD symptoms can be debilitating and range from deep despair, frequent crying to thoughts of hurting the baby, feeling disconnected from the child, or feeling like it belongs to someone else.
In a statement Friday, the FDA called Zuranolone “the first oral drug indicated for the treatment of postpartum depression in adults.”
It added: ‘Until now, treatment for PPD was only available as an IV injection given by a healthcare provider in certain healthcare facilities.”
The pill, designed specifically for PPD, has been shown to work faster than other antidepressants and is designed to be taken for only a short two-week period.
Trials of the pill showed that the side effects were less severe than other antidepressants currently in use, which can lead to sudden loss of consciousness, weight gain or sexual dysfunction.
It was developed by the pharmaceutical companies Biogen and Sage Therapeutics. No price has yet been announced for the new pill.
Tiffany Farchione, chief of psychiatry at the FDA’s Center for Drug Evaluation and Research, said PPD “is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness — even, in severe cases, thoughts about themselves or their child.”
“Having access to oral medications will be a beneficial option for many of these women dealing with extreme and sometimes life-threatening feelings,” she said.
Dr. Asima Ahmad, chief medical officer at Carrot Fertility, a health care company in Menlo Park, Calif., said about 75 percent of moms who report PPD symptoms go untreated.
‘These numbers have been increased for minorities; 81 percent of Black women and 76 percent of Hispanic women said they would have liked to learn more about postpartum mental health before having children, compared to 70 percent of women overall,” she said.
“At a time when we are seeing rising maternal mortality rates and significant racial disparities in maternal outcomes, we need to focus on solutions, and that includes addressing postpartum depression.”
In a statement on Friday, the FDA named zuranolone “the first oral drug indicated for the treatment of postpartum depression in adults”
Dr. Kristina Deligiannidis, who led the research on the drug, told CBS Saturday Morning, “Women reported rapid improvement in their depression as early as day three.”
Ahmad believes the new drug will reduce the stigma surrounding antidepressant use.
“Both the lower incidence of side effects and the short-term regimen, which could help some feel less stigma around taking an antidepressant, could improve adherence,” she said.
Zuranolone belongs to a class of drugs that target GABA receptors in the brain using a substance called a neurosteroid.
It is designed to quickly rebalance dysregulated brain networks responsible for functions such as mood, arousal, behavior and cognition, to help reset brain function.
When a person is depressed, GABA and glutamate, both neurotransmitters, are thrown off balance, which affects neuron activity.
Depression treatments usually focus on increasing serotonin levels in the brain, but a growing body of research shows that the GABA pathway may be just as effective.
The drug companies sought approval based on the strength of their five major depressive disorder studies and two PPD studies.
In the randomized phase 3 SKYLARK trial, women who received the drug at a dose of 50 mg felt measurably better after three days.
They measured women with PPD based on the 17-item Hamilton Rating Scale for Depression (HAMD-17).
A score of zero to seven is considered normal, while a score of 20 or higher (indicating at least moderate severity) is usually required for participation in a clinical trial.
Women were enrolled if they were less than six months postpartum and had a major depressive episode that started during the third trimester or before four weeks postpartum.
Clinical trials showed that zuranolone improved the symptoms of new mothers who experienced major depression after having a baby. (file image)
Lindsay Clancy, 32, is accused of killing her daughter Cora, 5, and son Dawson, 3, at the family home in Massachusetts and assaulting baby Callan, who is eight months old. Pictured LR: Lindsay, Dawson, Corey and husband Patrick
Women who received Zuranolone every night for two weeks experienced greater reductions in HAMD scores than women who received a placebo pill.
At day 15, the mean decrease in HAMD scores was 15.6 in women receiving Zuranolone versus 11.6 in the placebo group.
At day 45, women treated with Zuranolone still showed greater reductions in HAMD scores than women receiving placebo (17.9 points and 14.4 points lower, respectively).
Dr. Kristina Deligiannidis, who led the research on the drug, told CBS Saturday Morning, “Women reported rapid improvement in their depression as early as day three.”
She added that the medication had side effects such as drowsiness, sedation and headaches.
One woman said Zuranolone helped her from day one. “I immediately felt more like myself. It’s going to save so many women and families.”
More attention has come to PDD after Boston mom Lindsay Clancy, 32, allegedly killed her three children in January after suffering from an extreme form of postpartum depression.
In more extreme cases, a new mother may experience postpartum psychosis, the condition Clancy would have had when she committed the murders.
It is a rare condition that usually develops within the first week after giving birth. A new mother with psychosis will have an altered experience of reality that interferes with their ability to function normally.
Postpartum psychosis, which tends to include paranoia, dramatic mood swings, hallucinations, delusions, and suicidal and/or homicidal thoughts, is treatable.
Mental health professionals have an army of antidepressants at their disposal. The medication does not have to be tailored to PPD symptoms to work. Talk therapy is also a helpful tool for millions of women struggling after pregnancy.