US-based drugmakers Biogen and Sage Therapeutics have secured the US Food and Drug Administration (FDA) approval for Zurzuvae (zuranolone) 50mg to treat adults with postpartum depression (PPD).
Zurzuvae is an oral, once-daily, 14-day treatment designed to provide rapid improvements in depressive symptoms for women with PPD.
The drug is planned to be commercially launched in the fourth quarter of this year, following scheduling by the US Drug Enforcement Administration, which is expected within 90 days.
Zurzuvae label comes with a boxed warning that the drug causes driving impairment due to central nervous system (CNS) depressant effects.
People who take the drug should not drive or engage in other potentially dangerous activities, until at least 12 hours after administration for the duration of the 14-day treatment course.
In addition to approval, the FDA has issued a Complete Response Letter (CRL) for a New Drug Application (NDA) for zuranolone to treat the major depressive disorder (MDD) in adults.
According to the CRL, the application lacks substantial evidence to support the approval of Zurzuvae for the treatment of MDD, and additional studies may be required.
Biogen president and CEO Christopher A Viehbacher said: “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.
Sage Therapeutics CEO Barry Greene said: “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.
“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.”
The FDA approval of Zurzuvae is based on the NEST clinical development programme, which includes ROBIN and SKYLARK studies in adult women with PPD.
In both studies, the drug resulted in a significant reduction in the Hamilton Rating Scale for Depression at 15 days, compared to placebo, which is the primary endpoint.
The SKYLARK Study met all the key secondary endpoints, with Zurzuvae significantly reducing the depressive symptoms as early as Day-3 and sustained through Day-45.
Zurzuvae was generally well-tolerated with a consistent safety profile across both studies.
The most common side effects in the clinical studies include somnolence, dizziness, diarrhoea, fatigue and urinary tract infection.
ZURZUVAE clinical development programme principal investigator Kristina Deligiannidis said: “Today marks a ground-breaking 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.
“As a perinatal psychiatrist, I see the devastating impact PPD has on mothers, particularly on the important mother-infant bond and long-term child development. Once available, I believe Zurzuvae will be a meaningful option for patients in need.”
