FDA approves Zuranolone, the first pill EVER to treat postpartum depression -suffered by


The Food and Drug Administration has approved the first ever pill to treat postpartum depression (PPD) which is suffered by around one in seven new mothers. 

Zuranolone, which is an antidepressant, is a once-a-day pill, taken for two weeks. It will be sold under the brand name Zurzuvae.

Clinical trials showed it improved the symptoms of new mothers who were experiencing severe depression after having a baby. 

The only other medication on the market for PPD, Zulresso, needs to be administered via IV continuously 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, not feeling connected to the child, or feeling as if it is someone else’s.

The Food and Drug Administration has approved the first ever pill to treat postpartum depression (PPD) which is suffered by around one in seven new mothers

The Food and Drug Administration has approved the first ever pill to treat postpartum depression (PPD) which is suffered by around one in seven new mothers

Zuranolone, which is an antidepressant, is a once-a-day pill which is to be taken for two weeks. It will be sold under the brand name Zurzuvae

Zuranolone, which is an antidepressant, is a once-a-day pill which is 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, not feeling connected to the child, or feeling as if it's someone else's

PPD symptoms can be debilitating and range from deep despair, frequent crying to thoughts of hurting the baby, not feeling connected to the child, or feeling as if it’s someone else’s

In a statement on Friday, the FDA called Zuranolone ‘the first oral medication indicated to treat postpartum depression in adults’. 

It added: ‘Until now, treatment for PPD was only available as an IV injection given by a health care provider in certain health care facilities.’

The pill, specifically designed for PPD, has been shown to work faster than other antidepressants and is designed to be taken only over a short two-week period.

Trials of the pill showed its 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 pharmaceutical companies Biogen and Sage Therapeutics. No price has yet been announced for the new pill.

Tiffany Farchione, head of psychiatry in 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 of harming themselves or their child.’

‘Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings,’ she said.

Dr Asima Ahmad, chief medical officer at Carrot Fertility, a healthcare company in Menlo Park, California, said around 75 percent of moms reporting PPD symptoms go untreated.

‘These numbers are elevated for minority populations; 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.

‘In 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 called zuranolone 'the first oral medication indicated to treat postpartum depression in adults'

In a statement on Friday, the FDA called zuranolone ‘the first oral medication indicated to treat postpartum depression in adults’

Dr Kristina Deligiannidis, who led the study into the drug, told CBS Saturday Morning: 'Women were reporting rapid improvement in their depression as early as day three'

Dr Kristina Deligiannidis, who led the study into the drug, told CBS Saturday Morning: ‘Women were reporting rapid improvement in their depression as early as day three’

Ahmad believes the new drug will reduce the stigma around using antidepressants.

‘Both the lower incidence of side effects and the short-term regimen, which could help some feel less stigma around having to use an antidepressant, could potentially improve compliance,’ she said. 

Zuranolone is one in a class of drugs that target GABA receptors in the brain using a substance called a neurosteroid.

It was designed to rapidly 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 out of balance, affecting neuron activity.

Depression treatments typically aim to boost 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 trials in major depressive disorder and two trials in PPD.

In the Phase 3 SKYLARK randomized study, women receiving the drug at a 50mg dose 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 to be normal, while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.

Women were enrolled if they were less than six months postpartum and had a major depressive episode beginning during the third trimester or before four weeks postpartum.

Clinical trials showed zuranolone improved the symptoms of new mothers who were experiencing severe depression after having a baby.  (file image)

Clinical trials showed zuranolone improved the symptoms of new mothers who were experiencing severe depression after having a baby.  (file image)

Mrs Clancy, 32, is accused of killing her daughter Cora, 5 and son Dawson, 3, at the family home in Massachusetts and attacking baby Callan, who is eight months old. Pictured L-R: Lindsay, Dawson, Corey and husband Patrick

Lindsay Clancy, 32, is accused of killing her daughter Cora, 5 and son Dawson, 3, at the family home in Massachusetts and attacking baby Callan, who is eight months old. Pictured L-R: Lindsay, Dawson, Corey and husband Patrick 

Women who received Zuranolone each evening for two weeks experienced a greater reduction in HAMD scores than women receiving a placebo pill.

At day 15, the mean reduction in HAMD scores was 15.6 in women receiving Zuranolone vs. 11.6 in the placebo group.

At day 45, women treated with Zuranolone continued to show a greater reduction in HAMD scores than women receiving a placebo (down 17.9 points and 14.4 points, respectively).

Dr Kristina Deligiannidis, who led the study into the drug, told CBS Saturday Morning: ‘Women were reporting rapid improvement in their depression as early as day three.’

She added that the medication had side effects of feeling sleepy, sedation and headaches. 

One woman said Zuranolone helped her from day one. ‘I immediately just felt more like myself. It’s going to save so many women and families.’ 

Increased focus has been put on PDD after Boston mother Lindsay Clancy, 32, allegedly murdered 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 that Clancy is believed to have had when she committed the murders.

It’s a rare condition that usually develops within the first week after delivery. A new mother with psychosis will have an altered experience of reality which interferes with their ability to function normally.

Postpartum psychosis, which tends to include paranoia, dramatic mood changes, hallucinations, delusions, and suicidal and/or homicidal thoughts is treatable.

Mental health professionals have a full army of antidepressant drugs at their disposal. The medication does not have to be tailored to PPD symptoms to work. Talk therapy is also a useful tool for millions of women struggling post-pregnancy.



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