U.S.-based pharma major Sage Therapeutics and global biotechnology firm Biogen recently announced that the USFDA granted approval for the first oral medication for women with postpartum depression, marketed as Zurzuvae (Zuranolone,50mg).

Postpartum Depression(PPD)  is a major depressive disorder caused due to mental and physical changes that occur during pregnancy and childbirth. This issue in women starts during pregnancy and continues after childbirth. 

Until now, an IV injection from a doctor was the only available treatment for this issue.

Similar to other forms of depression, postpartum depression also causes sadness and loss of interest in previously enjoyable activities. Some patients may experience fatigue, anxiety, and cognitive impairment, and sometimes have suicidal thoughts.

Speaking on the recent approval, Dr  Tiffany R. Farchione, Director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, said, “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.” 

“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”Dr  Farchione added.

The approval of the FDA is based on a  randomised, placebo-controlled clinical trial study conducted on women with postpartum depression, which shows the data about the efficacy of the Zurzuvae.

Chief Executive Officer at Sage Therapeutics, Barry Greene, highlighted the need for the product, saying, “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.”

Furthermore, the FDA granted a Complete Response Letter (CRL) for Zuranolone's New Drug Application (NDA) for the treatment of adults with major depressive disorder (MDD). 

The CRL pointed out that the application did not present sufficient evidence of efficacy to support the approval of Zuranolone for the treatment of MDD and that further research will be required.

Officials of Sage and Biogen, who have jointly developed the drug said that they are studying the feedback and deciding what steps to take next.

“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,” Greene said.

According to experts, one in seven women experience PPD in the United Kingdom where approximately, 600,000 cases of PPD are reported annually. 

Emphasising the importance of approval  Christopher A. Viehbacher, President and Chief Executive Officer at Biogen, “The approval of Zurzuvae to treat postpartum depression is a major milestone for the hundreds of thousands of women who experience this underdiagnosed and undertreated condition.” 

Furthermore, he added, “We appreciate the support of patients, patient advocates and researchers who helped to reach this milestone”. We believe that Zurzuvae will be an important option to treat PPD and we will thoroughly review the feedback from the FDA on the use of quinolone in MDD to determine the next steps.”