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General Information
Zurzuvae (zuranolone) is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator.
Zurzuvae is specifically indicated for the treatment of postpartum depression (PPD) in adults.
Dosing/Administration
- Zurzuvae is supplied as capsules for oral administration.
- The recommended dosage of Zurzuvae is 50 mg taken orally once daily in the evening for 14 days.
- Administer Zurzuvae with fat-containing food (e.g., 400 to 1,000 calories, 25% to 50% fat).
- If patients experience CNS depressant effects within the 14-day period, consider reducing the dosage to 40 mg once daily in the evening within the 14-day period.
- Zurzuvae can be used alone or as an adjunct to oral antidepressant therapy. The safety and effectiveness of Zurzuvae use beyond 14 days in a single treatment course have not been established.
Mechanism of Action
The mechanism of action of zuranolone in the treatment of PPD is not fully understood, but is thought to be related to its positive allosteric modulation of GABAA receptors.
Side Effects
Adverse effects associated with the use of Zurzuvae may include, but are not limited to, the following:
- somnolence
- dizziness
- diarrhea
- fatigue
- nasopharyngitis
- urinary tract infection
The Zurzuvae drug label comes with the following Black Box Warning: Zurzuvae causes driving impairment due to central nervous system (CNS) depressant effects. Advise patients not to drive or engage in other potentially hazardous activities until at least 12 hours after administration. Patients may not be able to assess their own driving competence or the degree of impairment caused by Zurzuvae.
Clinical Trial Results
The FDA approval of Zurzuvae 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.