The US Food and Drug Administration has approved Biogen and Sage Therapeutics’ postpartum depression pill (PPD), reports Reuters.
The companies had also sought approval for the zuranolone, to be marketed under the brand name Zurzuvae, to treat major depressive disorder (MDD) and clinical depression in adults, Reuters reports.
PPD, a condition that affects around one in every seven women giving birth, and which has become one of the leading causes of maternal mortality in the US, severely affects a woman’s ability to return to normal functioning, while also potentially affecting her relationship with her child.
“Zurzuvae is expected to launch and be commercially available in the fourth quarter of 2023 shortly after scheduling as a controlled substance by the Drug Enforcement Administration, which is anticipated within 90 days,” the companies said.
The statement said the FDA issued a Complete Response Letter for the New Drug Application for Zurzuvae in the treatment of adults with MDD – but that the application did not provide substantial evidence of its effectiveness for treating of MDD, and that additional studies would be needed to support the approval.
Until now, treatment for postpartum depression was available only as an intravenous injection.
Experts have heralded the approval of Zurzuvae for once-daily use over 14 days. Its ability to address mental health issues much more quickly than other available pills will make it particularly effective for postpartum depression during the crucial first days after childbirth, when women are bonding with their babies, they said.
In addition to being fast-acting, clinical trials showed that the effects of Zurzuvae held for four weeks after the last dose, the FDA said, with the caveat that the trials did not follow up with patients’ past 45 days.
Some women are particularly vulnerable to postpartum depression, Judite Blanc, an assistant professor of psychiatry and behavioural sciences at the University of Miami’s Miller School of Medicine told The Washington Post. “In a nutshell, it’s about stress and traumatic exposure.”
Before the approval of Zurzuvae, the only FDA-approved treatment for postpartum depression was Zulresso, an IV injection that could only be given in healthcare facilities and would take as much as 60 hours to administer. The new pill, which acts similarly to the IV injection, greatly expands access because it can be easily taken at home.
There are some other key differences between the two drugs. While Zulresso was shown to affect patients’ moods within 24 hours, the pill takes a few days to kick in, which is still a much shorter timeline than other anti-depression drugs.
An important caveat is that the clinical trials have primarily included women with severe postpartum depression, not those experiencing the more common range of symptoms that are more mild or moderate, said Catherine Monk, a professor of medical psychology at Columbia University.
For that latter group, she said non-medical interventions like therapy and lifestyle changes aimed at lowering anxiety levels may be more suitable.
For “someone with serious depression … this new medication is an absolute great step,” she added.
Reuters article – FDA approves oral pill for postpartum depression for first time (Open access)
The Washington Post article (Restricted access)
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Perinatal depression: mums, dads, babies all at risk – London meta-analysis
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