FDA approves zuranolone, the first oral pill for postpartum depression.

The FDA Approves Zurzuvae: A Breakthrough Pill ​for Postpartum Depression

The Food and Drug Administration has recently given its approval for zuranolone, known by its brand name Zurzuvae, making​ it ⁢the first-ever pill treatment for⁢ postpartum depression ⁣(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.”

“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,” expressed Jenna Carber, founder of PostpartumDepression.org, in an interview⁢ with 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, experiencing symptoms such as hopelessness, ​lack​ of appetite, and difficulty ‌bonding with their baby. In severe cases, women with PPD or the rare condition postpartum psychosis can even have thoughts ⁤of⁣ self-harm and harming their child.

What sets ‍PPD apart ‌from other ‍depression disorders‌ is its connection to the significant hormonal changes in estrogen and progesterone levels after childbirth. Women with ⁢a family history of PPD ‍are also more ​likely to experience symptoms. Zuranolone, an oral neuroactive steroid therapy, targets the root causes of PPD and can be taken at home.

“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,” stated 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, and after 15 days of treatment, 57% of patients experienced a 50% or more improvement ‌in their PPD symptoms. By day 45, this number increased to 61.9%.

CLICK HERE TO READ MORE FROM THE WASHINGTON EXAMINER

In 2019, the FDA approved​ Zulresso, an IV treatment for PPD, to address the most severe cases. However, Zulresso must⁤ be administered in a hospital or qualified healthcare⁢ facility 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,” emphasized Carber.⁢ “We stand with those⁢ who are affected⁢ by ​postpartum depression and hope that this medication will ‌bring them⁢ healing.”