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First Pill for Postpartum Depression Approved by FDA

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The first oral pill specifically for the treatment of postpartum depression (PPD) – Zurzuvae™ (zuranolone) – has been granted fast track approval by the US Food and Drug Administration (FDA). According to data from two Phase 3 clinical trials, a 2-week course of daily zuranolone provided rapid improvements in PPD symptoms at day 15 of treatment, and for some patients from as early as day 3.

A pill for PPD

Approximately one in seven women develop PPD. Thought to be a result of a combination of factors such as hormonal changes and sleep deprivation, PPD typically occurs after birth but can also begin during the later stages of pregnancy.

PPD is characterized by symptoms such as sadness, loss of interest in activities and a decreased ability to feel pleasure. These can also present alongside cognitive impairment, feelings of inadequacy, loss of energy and suicidal ideation.

“Postpartum depression 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. And, because postpartum depression can disrupt the maternal–infant bond, it can also have consequences for the child’s physical and emotional development,” said Dr. Tiffany R. Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, in a press release from the FDA.

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The only other available treatment specifically for PPD, brexanolone, was approved in 2019. However, this is only available as an IV infusion, requiring it to be administered by a healthcare professional in a clinical setting and coming at a significant cost. Research shows that just 15.8% of women with PPD symptoms go on to receive treatment, highlighting the need for better and more easily accessible treatments. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings,” Farchione added.

Zuranolone, produced by biopharmaceutical companies Biogen and Sage Therapeutics, is an oral medication that targets the GABA system, a major signaling pathway that regulates the central nervous system. It has now been approved by the FDA as the first oral medication for the treatment of PPD.

Rapid improvement in symptoms

Data from clinical trials show that a once-daily course of zuranolone for 14 days led to improvements in depressive symptoms. The two trials – SKYLARK and ROBIN – were performed in women with PPD to assess the efficacy of zuranolone compared to placebo.

In the SKYLARK study, patients received either a 50 mg dose of zuranolone (98 patients) or a placebo (also 98 patients) every evening over a 2-week period. In the ROBIN study, patients received either a placebo (74 patients) or 30 mg zuranolone (76 patients), also over a 2-week period.

Both studies met their primary goal. Zuranolone treatment led to a significant reduction in depressive symptoms on day 15 after starting treatment, measured by the widely used Hamilton depression rating scale (HAMD-17). These improvements in depressive symptoms were also sustained at four weeks after the last dose.

“Today marks a groundbreaking day for the treatment of PPD, as with Zurzuvae we now have an oral treatment option that can provide rapid improvements in depressive symptoms in as early as three days for women with PPD,” said Dr. Kristina Deligiannidis, a principal investigator in the Zurzuvae clinical development program and associate professor at the Feinstein Institutes for Medical Research. “As a perinatal psychiatrist, I see the devastating impact PPD has on mothers, particularly on the important mother–infant bond and long-term child development. Once available, I believe Zurzuvae will be a meaningful option for patients in need.”

The most common side effects that occurred in over 10% of patients included drowsiness and dizziness, necessitating a boxed warning from the FDA advising that zuranolone can impact the ability to drive or perform other potentially hazardous activities for 12 hours after each dose. Zuranolone is also due to be scheduled as a controlled substance by the FDA and is expected to be commercially available in late 2023.

“Today’s approval is welcome news for the estimated 500,000 women in the United States who report experiencing symptoms of this devastating and often misunderstood illness each year,” said Dr. Wendy N. Davis, executive director at Postpartum Support International. “Women with PPD desperately need prompt care and additional treatment options that can provide quick relief so they can be healthy and present during this momentous time in their lives.”

This article is a rework of a press release issued by the FDA. Material has been edited for length and content.