FDA approves first postpartum depression oral pill zuranolone
Gabrielle M. Etzel
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The Food and Drug Administration has approved zuranolone, brand name Zurzuvae, the first-ever pill treatment for postpartum depression, or PPD.
“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,” said Tiffany R. Farchione, the FDA’s director of the Division of Psychiatry in the 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.”
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“It is heart-wrenching to think about the struggles that women face when dealing with postpartum depression after giving birth. Thankfully, this once-overlooked issue is now receiving more attention and recognition,” Jenna Carber, founder of PostpartumDepression.org, told the Washington Examiner. “We are grateful for the groundbreaking progress that pharmaceutical companies have made in creating a pill-based treatment.”
Approximately 1-in-7 women can develop PPD, with symptoms ranging from hopelessness, lack of appetite, and difficulty bonding with their baby. In the most severe cases, women with PPD or the rare condition postpartum psychosis can experience thoughts of self-harm and harming their child.
PPD is different than other depression disorders because of its connection to the dramatic changes in estrogen and progesterone hormone levels after birth. Women with family histories of PPD are also more likely to experience symptoms. Zuranolone is an oral, at-home neuroactive steroid therapy that treats the root causes of PPD.
“Postpartum depression is underrecognized, undertreated and disruptive for those who live with the condition. We collaborate with researchers around the world in an effort to develop more rapid and effective therapies for the many women who need support,” said Kristina Deligiannidis, the lead physician at the Feinstein Institute for Medical Research who conducted the 196-person clinical trial used in the FDA’s review.
Zuranolone is taken once a day for 14 days. After 15 days of treatment, 57% experienced a 50% or more improvement in their PPD symptoms. At 45 days, 61.9% experienced improvement.
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In 2019, the FDA approved an IV treatment for PPD, Zulresso, to address the most severe cases of PPD. Zulresso must be administered in a hospital or qualified healthcare facility, however, due to the risk of losing consciousness during treatment.
“Upon approval by the FDA, It is essential that insurance providers cover this medication so that it can potentially save lives and keep families together, provided that it proves to be effective,” Carber said. “We stand with those who are affected by postpartum depression and hope that this medication will bring them healing.”