FDA Approves Postpartum Depression Drug

In a groundbreaking move, the FDA has approved ZURZUVAE (zuranolone), a pill specifically designed to treat postpartum depression (PPD) in new mothers. This decision marks a significant step forward for new mothers and the medical community, offering a targeted treatment option for a condition that affects women worldwide. Recent studies have highlighted the prevalence and impact of PPD, emphasizing the need for effective treatments. ZURZUVAE was developed by Sage Therapeutics and Biogen Inc. according to the official press release.

“Maternal mental health has been sidelined for far too long, but today’s approval of ZURZUVAE helps to change that. Women have been waiting for an oral medicine that can specifically and rapidly improve the symptoms of PPD and we are proud to be able to deliver that,” said Barry Greene, Chief Executive Officer at Sage Therapeutics. “In regard to the CRL for MDD, we are highly disappointed for patients, particularly amid the current mental health crisis and millions of people with MDD struggling to find symptom relief. We remain committed to our mission to deliver life-changing brain health medicines.” 

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What is PPD?

Postpartum depression is a mood disorder that can affect women after childbirth. This can be caused due to the change in hormone levels after childbirth. Women with underlying depression or anxiety, or have a family history may be at greater risk. The American Psychological Association estimates that up to 1 in 7 women experience PPD.

“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 Wendy N. Davis, Ph.D., PMH-C, 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.” 

PPD can often be overlooked as “baby blues” or an “overtired” new mother but that’s not the case. PPD manifests in mothers differently, including, 

• A loss of interest in things previously enjoyed

• Eating less or more than typical

• Racing and/or scary thoughts

• Anxiety or panic attacks

• Blaming yourself

• Feelings of worthlessness or guilt

• Disinterest in baby, significant other, family, and/or friends

• Inability to sleep or over-sleeping

• Fear of not being a good mother

• Afraid to be alone with baby/children

• Overwhelming sadness

• Crying uncontrollably 

What is ZURZUVAE?

• Name of the pill: ZURZUVAE (zuranolone)

• Description: ZURZUVAE is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator. It has been specifically indicated for the treatment of postpartum depression in adults.

Usage and dosage

Source: FDA-approved document on ZURZUVAE

How the pill differs from other treatments

ZURZUVAE offers a unique approach to treating PPD. Unlike traditional antidepressants, ZURZUVAE is a neuroactive steroid that modulates the GABA A receptor. This mechanism might offer advantages over other treatments, though patients should discuss potential risks and benefits with their doctor.

The medication causes central nervous system (CNS) depression so individuals should not drive for at least 12 hours after taking the medication and for the duration of the entire 14-day treatment course. 

Medical professionals weigh in

Leading obstetricians and psychologists have weighed in on the FDA's approval of ZURZUVAE.

Dr. Natalie Azar emphasized the potential game-changing nature of this treatment. She highlighted:

• The previous treatment for postpartum depression required a 60-hour hospital stay, making it impractical for many.

• Traditional interventions, like antidepressants and psychotherapy, can take weeks or even months to show results.

• The new pill, with its rapid onset and the convenience of being taken at home, is set to revolutionize the treatment landscape.

• The FDA's approval is specifically for women with severe postpartum depression, excluding those with mild or moderate symptoms.

• Clinical trials indicated the treatment's lasting effect, with none of the participants requiring retreatment up to 45 days post-treatment.

Dr. Sheryl Kingsberg, Division Chief of OB/GYN behavioral medicine at UH Cleveland Medicinal Center, shared her insights:

• Postpartum depression affects 10 to 15 percent of women who give birth, yet it remains understudied and often unrecognized.

• The recent drug approval specifically addresses the hormonal and steroid changes during pregnancy, distinguishing it from general antidepressants.

• ZURZUVAE, the new oral medication, requires only a two-week course of treatment, offering a more convenient alternative to the previously approved 60-hour infusion.

• Postpartum depression can last for weeks to months, and if untreated, can persist for over a year, impacting the quality of life for both mother and baby.

• Postpartum depression manifests in two distinct ways: one characterized by anxiety and the other by a loss of interest and feelings of hopelessness.

FDA's statement

The FDA provided a comprehensive overview of ZURZUVAE, detailing its clinical trial experiences, potential adverse reactions, and the rigorous process that led to its approval. Their endorsement underscores the drug's potential in addressing the challenges of postpartum depression.

“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 Tiffany R. Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”

What this means for providers?

Manufacturers expect ZURZUVAE to be available starting in the fall/winter 2023 following scheduling as a controlled substance by the U.S. Drug Enforcement Administration (DEA). Practitioners that will prescribe ZURZUVAE should be well versed in the medication and possible side effects which may include, somnolence, dizziness, diarrhea, and fatigue. The biggest concern for healthcare providers is the inability of new mothers to drive immediately after taking the medication during the 14 day course. 

The FDA's approval of ZURZUVAE marks a significant milestone in the treatment of postpartum depression. This new medication offers a beacon of hope for countless women and their families. As with any medication, it's essential for individuals to consult with their healthcare provider before starting a new treatment.