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New York: The US Food and Drug Administration has approved the first pill for post-natal depression, a milestone considered likely to increase recognition and treatment of a debilitating condition that afflicts about a half-million women in the United States alone every year.
Clinical trial data show the pill works quickly, beginning to ease depression in as little as three days, significantly faster than general antidepressants, which can take two weeks or longer to have an effect. That – along with the fact that it is taken for just two weeks, not for months – may encourage more patients to accept treatment, maternal mental health experts said.
The new pill is expected to help treat more women for post-natal depression more quickly.Credit: Shutterstock
The most significant aspect of the approval may not be the features of the drug, but that it is explicitly designated for postpartum depression. Several doctors and other experts said that while there were other antidepressants that were effective in treating the condition, the availability of one specifically shown to address it could help reduce the stigma of postpartum depression by underscoring that it has biological underpinnings and is not something women should blame themselves for.
The hope is that it will encourage more women to seek help and prompt more obstetricians and family doctors to screen for symptoms and suggest counselling or treatment.
“This is a patient population that just so often falls through the cracks,” said Dr Ruta Nunacs, a psychiatrist with the Centre for Women’s Mental Health at Massachusetts General Hospital. “When women are told, ‘You have postpartum depression’, it’s embarrassing, it is demeaning, it makes them feel like a bad mom.”
She added, “There’s also a lot of stigma about taking antidepressant medication, so that might make this treatment more appealing because it’s really a treatment specific for postpartum depression.”
An estimated 10 per cent to 15 per cent of women who give birth in the United States experience depression during pregnancy or in the year afterwards. The condition can be accompanied by intense anxiety, shame, guilt, impaired sleep, panic attacks and suicidal thoughts or attempts. And it can make it difficult for mothers to provide their babies with the care, bonding and nurturing that is crucial for healthy development.
The pill, zuranolone, which will be marketed under the brand name Zurzuvae, was developed by Sage Therapeutics, a Massachusetts company that produces it in partnership with Biogen. It is expected to be available in the US after the Drug Enforcement Administration completes a 90-day review required for drugs affecting the central nervous system, Sage said. The companies have not announced a price for the pill.
The only other drug approved for postpartum depression is brexanolone, also developed by Sage and marketed as Zulresso. But brexanolone, approved in 2019, requires a 60-hour intravenous infusion in a hospital, carries risks of loss of consciousness and costs $US34,000 ($51,000). Sage says only about 1000 patients have received it so far.
Taking a pill for two weeks is much easier, not requiring a mother to leave her baby for several days. However, the FDA did require the label to include warnings about possible suicidal thoughts and behaviour, sleepiness and confusion.
This article originally appeared in The New York Times.
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