Zurzuvae FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 6, 2023.
FDA Approved: Yes (First approved August 4, 2023)
Brand name: Zurzuvae
Generic name: zuranolone
Dosage form: Capsules
Company: Sage Therapeutics, Inc.
Treatment for: Postpartum Depression
Zurzuvae (zuranolone) is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of postpartum depression in adults.
- Postpartum depression (PPD) is a major depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy.
- Zurzuvae is thought to work in the treatment of postpartum depression via positive allosteric modulation of GABA-A receptors. The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes to regulating brain function. Altered neurotransmission of GABA has been implicated in the pathogenesis of depression.
- Zurzuvae contains the drug zuranolone, which was developed as an improvement to brexanolone (Zulresso) for the treatment of postpartum depression. Zuranolone has better bioavailability and can be administered orally compared to brexanolone which is administered via intravenous injection.
- FDA approval of Zurzuvae to treat PPD was 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. In the SKYLARK Study evaluating Zurzuvae 50 mg, all key secondary endpoints were met, with significant reduction in depressive symptoms seen as early as Day 3 and sustained through Day 45.
- Zurzuvae capsules are administered orally once daily in the evening with fat-containing food, for 14 days.
- The Zurzuvae product label carries a Boxed Warning for impaired ability to drive or engage in other potentially hazardous activities. People taking Zurzuvae are advised not to drive or engage in other potentially hazardous activities until at least 12 hours after administration.
- Warnings and precautions associated with Zurzuvae include CNS depressant effects such as somnolence and confusion, suicidal thoughts and behavior, and embryo-fetal toxicity. Females of reproductive potential should use effective contraception during treatment with Zurzuvae, and for one week after the final dose.
- Common adverse reactions include somnolence, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection.
- On August 4, 2023, in addition to the approval for Zurzuvae for PPD, 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 an additional study or studies would be needed.
Development timeline for Zurzuvae
Further information
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