Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) announced the U.S. Food and Drug Administration (FDA) approved ZURZUVAE (zuranolone) 50 mg for adults with postpartum depression (PPD). The treatment is the first of its kind, offering an oral, once-daily, 14-day course that can provide rapid improvements in depressive symptoms for women with postpartum depression . ZURZUVAE is anticipated to be commercially available in the fourth quarter of 2023, following its classification as a controlled substance by the U.S. Drug Enforcement Administration, expected within 90 days.

Complete Response Letter Issued for Major Depressive Disorder Treatment

In contrast, the FDA 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 indicated that additional study or studies would be necessary, as the application lacked substantial evidence of effectiveness for major depressive disorder treatment. Sage and Biogen stated that they are currently reviewing the feedback and considering the next steps.

CEO at Sage Therapeutics, Barry Greene, expressed pride in the approval for postpartum depression treatment, 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.” Regarding the CRL for MDD, Greene expressed disappointment, emphasizing the commitment to delivering life-changing brain health medicines.

Christopher A. Viehbacher, President and CEO at Biogen, also welcomed the approval and expressed gratitude to those who contributed to this milestone. He further assured that the feedback from the FDA on the use of zuranolone in major depressive disorder would be thoroughly reviewed.

The NEST Clinical Development Program and Side Effects

The approval of ZURZUVAE came after successful results in two studies within the NEST clinical development program. Both studies demonstrated significant reduction in depression severity, with key secondary endpoints met in the SKYLARK Study for ZURZUVAE 50 mg. The treatment was generally well-tolerated, though common side effects included somnolence, dizziness, diarrhea, fatigue, and urinary tract infection.

The labeling for ZURZUVAE also includes a warning about driving impairment due to central nervous system (CNS) depressant effects. Instructions for healthcare providers indicate that patients should avoid driving or engaging in potentially hazardous activities requiring complete mental alertness for at least 12 hours after administration during the 14-day treatment course.

ZURZUVAE represents a significant advancement in the treatment of adults with postpartum depression, filling a vital need in the medical community. The outcome for major depressive disorder treatment, however, remains to be seen, as Sage Therapeutics and Biogen navigate the feedback from the FDA.

  Barry Greene, Biogen, Christopher A Viehbacher, Depression, major depressive disorder, postpartum depression, Sage Therapeutics, US FDA, USA, zuranolone, ZURZUVAE