- Zuranolone, a new postpartum depression medication, has been approved by the FDA on August 4, 2023. It is the first FDA-approved oral pill in the United States specifically for postpartum depression. Zuranolone was found to be safe and effective in a Phase 3 trial. It is sold under the brand name Zurzuvae and has been approved as a once-daily pill taken over the course of 14 days.
- The FDA added a boxed warning to the drug’s labeling, noting it can impact a person’s ability to drive and perform other potentially hazardous activities. Patients also may not be able to assess their degree of impairment. To reduce the risk of harm, the agency says patients should not drive or operate heavy machinery for at least 12 hours after taking the drug.
- The most common side effects include drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis (the common cold), and urinary tract infection. The agency also said use of the drug may cause suicidal thoughts and behavior. It may also cause fetal harm. The agency said women should use effective contraception while taking, and for one week after taking the medication.
- How does Zuranolone work?
- Zuranolone is a new medication that affects the activity of GABA, an inhibitory neurotransmitter in the brain, reducing nerve cell firing and calming it. It acts as a positive allosteric modulator of the GABA A receptor, making it more sensitive to GABA, resulting in increased inhibition of nerve cells and reduced depression symptoms.
- It differs from other antidepressants like selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), which increase serotonin and/or norepinephrine levels in the brain. Zuranolone does not affect these neurotransmitters, resulting in fewer side effects.
- Also, it is different from benzodiazepines, which bind to a specific site on the receptor and increase the frequency of opening the chloride channel, causing sedation, muscle relaxation, and anti-anxiety effects. However, Zuranolone does not cause dependence, tolerance, withdrawal, memory impairment, or cognitive decline with long-term use.
- Zurzuvae is expected to launch and be commercially available in the fourth quarter of 2023 shortly following scheduling as a controlled substance by the U.S. Drug Enforcement Administration, which is anticipated to occur within 90 days. This means that Zurzuvae could be available in the market as early as November or December 2023, depending on the DEA’s decision and the distribution process.
