On Aug. 4, 2023, the U.S. Food and Drug Administration (FDA) issued two separate decisions for Zurzuvae^™ (zuranolone) capsules. Its manufacturer, Sage Therapeutics, and its partner, Biogen, received a complete response letter (CRL) requesting more information about its effectiveness before zuranolone can be approved for treating major depressive disorder (MDD). FDA approval was granted, however, for Zurzuvae’s use in treating adults who have postpartum depression (PPD). The positive modulator for neuroactive steroid gamma-aminobutyric acid (GABA) A receptors is the first oral drug indicated to relieve PPD. By itself or added to another oral antidepressant, it is taken for 14 days as one 50mg dose each evening along with a meal that contains fat. A boxed warning cautions that the ability to drive or do other complex tasks may be diminished, so patients should not attempt potentially dangerous actions within 12 hours of each dose. Zurzuvae is expected to be launched before the end of 2023 after the U.S. Drug Enforcement Administration (DEA) assigns it to a controlled substance schedule – usually within about three months from approval. It will be available through a large network of specialty pharmacies that doesn’t include Accredo. Pricing information is not yet known. Complete prescribing information is here.

At a Glance

• Brand (Generic) Name: Zurzuvae^™ (zuranolone)
• Manufacturer: Sage Therapeutics/Biogen
• Date Approved: Aug. 4, 2023
• Indication: to treat PPD in adults
• Dosage Forms Available: 20mg, 25mg, and 30mg oral capsules
• Launch Date: Fourth quarter 2023
• Estimated Annual Cost: Not yet available
• Depression is a common complication after childbirth. PostpartumDepression.org estimates that up to 85% of new mothers have “baby blues”, relatively short, mild forms of depression after giving birth.
• However, approximately 10% to 20% of new American mothers experience longer-lasting, more severe PPD. It can cause feelings of guilt or insignificance, impairments in physical functioning, problems with reasoning, or even thoughts of suicide or harm to the child. Serious PPD can begin during pregnancy, shortly after delivery, or weeks later. If PPD is untreated, symptoms may persist and depression may become chronic.
• In clinical trials that included women whose PPD began in the last three months before they gave birth or within four weeks after delivering the baby, symptoms began to ease for some participants as soon as three days after they started taking Zurzuvae. Its effects typically lasted 45 days or longer.
• As a central nervous system (CNS) depressant, Zurzuvae may cause drowsiness, dizziness, and fatigue. Other possible side effects may include cold-like symptoms, diarrhea, and urinary tract infections (UTIs).
• Patients should use a reliable form of contraception while taking Zurzuvae and for at least one week after stopping it.
• The only other drug presently approved specifically for PPD is Zulresso^® (brexanolone – Sage Therapeutics) injection C-IV. In the same drug class as Zurzuvae, it must be given by trained providers in registered healthcare facilities as a continuous intravenous (IV) infusion over 60 hours at varying dosage rates. Due to the risks of extreme sleepiness and lost or altered consciousness during the infusion, Zulresso has both a boxed warning and a risk evaluation and mitigation strategy (REMS). Patients, who must be enrolled in the REMS before receiving treatment, need continual monitoring during the entire infusion.
• Zurzuvae was approved under the FDA’s Fast Track and Priority Review programs.