What To Know Regarding A Potential FDA Approved Drug For Postpartum Depression

A condition known as the "baby blues" is commonly experienced after giving birth. The mood swings, anxiety, and sleep troubles that characterize the condition are often temporary, commonly lasting up to 14 days (via Mayo Clinic). However, in cases of postpartum depression, depression symptoms are often more severe and ongoing following childbirth.

According to 2022 research published in StatPearls, roughly 1 in 7 women are susceptible to developing postpartum depression (PPD). Now, in a news release issued February 6, Biogen and Sage Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted the company's application requesting approval of a fast-acting, once-daily drug known as Zuranolone for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Not only has the submission been accepted for evaluation, but the FDA has also issued "priority review" of the medication.

"We see potential for zuranolone, if approved, to be a meaningful new option that can help address the serious unmet need faced by the diverse populations struggling with MDD and PPD," said Dr. Priya Singhal, executive vice president, head of development and interim head of Research and Global Safety and Regulatory Sciences at Biogen, via the press release.

Designed to be taken once a day, Zuranolone is an oral neuroactive steroid (NAS) that works by modulating GABA receptors in the brain. As a fast-acting drug, Zuranolone is designed to restore balance to an imbalance of neuronal networks that play a role in mood, behavior, cognition, and arousal, as per the press release. According to a 2020 scientific review published in Neuron, when one is not in a state of stress, GABA levels are shown to be balanced. When one experiences depression or states of ongoing stress, however, research shows a drop in GABA, as well as other related neurotransmitters, demonstrating a potential link between the two.

Currently being evaluated as a 14-day rapid-acting medication, experts emphasize the significance the drug could have in terms of treating depression symptoms in patients more quickly than many existing treatment medications. "Most current approved therapies may take weeks or months to work," Dr. Laura Gault, chief medical officer at Sage, stated in the news release. "We are committed to advancing treatments that could help physicians and patients by addressing depression symptoms quickly. We believe zuranolone, if approved, could offer a new way for physicians to support patients."

If you or someone you know needs help with mental health, please contact the Crisis Text Line by texting HOME to 741741, call the National Alliance on Mental Illness helpline at 1-800-950-NAMI (6264), or visit the National Institute of Mental Health website.