USA – The United States Food and Drug Administration (FDA), has approved Biogen’s and Sage Therapeutic’s oral medication for the treatment of postpartum depression (PPD) in women.
ZURZUVAE is the first and only oral, once-daily, 14-day treatment that can provide rapid improvements in depressive symptoms for women with PPD.
The treatment is expected to be launched and be commercially available in the fourth quarter of 2023 shortly following scheduling as a controlled substance by the U.S. Drug Enforcement Administration, which is anticipated to occur within 90 days.
Until now, treatment for postpartum depression in the US was only available in the form of an intravenous injection.
The drug, Brexanolone, requires a 60-hour intravenous infusion in a hospital and costs about US$34,000, according to the New York Times.
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.”
Viehbacher also acknowledged the support of patients, patient advocates and researchers who helped the partners reach the milestone and he believed that ZURZUVAE would be an important option to treat PPD.
The approval of ZURZUVAE to treat women with PPD is based on the NEST clinical development program, which included two studies in adult women with PPD (ROBIN and SKYLARK Studies).
“Both studies met their primary endpoint, a significant mean reduction from baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score, a common measure of depression severity, at Day 15 as compared to placebo,” noted the joint statement from Biogen and Sage.
The statement continued to note that in the SKYLARK Study evaluating ZURZUVAE 50 mg, all key secondary endpoints were met, with a significant reduction in depressive symptoms seen as early as Day 3 and sustained through Day 45.
Barry Greene, Chief Executive Officer at Sage Therapeutics said, “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.”
A momentous milestone in the management of tormenting mental health condition
“Today marks a groundbreaking day for the treatment of PPD, as with ZURZUVAE we now have an oral treatment option that can provide rapid improvements in depressive symptoms in as early as three days for women with PPD,” said Dr. Kristina Deligiannidis, a principal investigator in the ZURZUVAE clinical development program and Professor, The Feinstein Institutes for Medical Research in Manhasset, New York.
According to the Centers for Disease Control and Prevention, the mental health condition is the leading cause of maternal mortality and is actually very common with women during and after pregnancy.
In the U.S., the CDC estimates approximately 1 in 8 women experience symptoms of PPD.
Additionally, approximately half of all PPD cases may go undiagnosed without appropriate screening and research shows only 15.8% of women with PPD symptoms receive treatment.
PPD symptoms may persist beyond the postpartum period and can lead to prolonged maternal morbidity.
The CDC lists the symptoms of PPD to include depressed mood, loss of interest in activities, changes in sleep patterns and appetite, decreased energy, feelings of guilt or worthlessness, trouble concentrating, and in some cases thoughts of suicide.
“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.
Dr. Wendy added that women with PPD desperately need prompt care and additional treatment options that can provide quick relief so they can be healthy and be present during this momentous time in their lives.
Bitter-sweet news for Biogen and Sage
Despite the positive news, the FDA also issued a complete response letter (CRL) for the New Drug Application (NDA) for zuranolone in the treatment of adults with major depressive disorder (MDD).
The CRL stated that the application did not provide substantial evidence of effectiveness to support the approval of zuranolone for the treatment of MDD and that additional study or studies will be needed.
In a joint statement, both companies have noted they are reviewing the response from the regulator and evaluating the next steps.
Greene in his statement said, “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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