The FDA approved Zurxuvae after reviewing the results of two randomized, double-blind, placebo-controlled, multicenter studies.
In the first study, individuals diagnosed with PPD consumed either 50 milligrams of Zurxuvae or a placebo once daily for 14 days. In the second study, individuals with PPD consumed a zuranolone product equal to 40 milligrams of Zurzuvae or a placebo once daily for 14 days. Researchers followed individuals in both studies for at least four weeks after the studies concluded, observing that those who received Zurxuvae showed “significantly more improvement in their symptoms” than participants who received a placebo.
“This drug is extremely promising, as it has rapid action—only 14 days, which is significant compared to most psychiatric medications (which can take up to a month to have a full effect),” notes Dr. Romanoff.
As excited as she is about this development, Dr. Oreck says there are still a few questions regarding accessibility and cost of this new medication. “We have yet to answer questions about affordability and how accessible it will be to those who need it most. Zuranolone’s predecessor (braxanolone) is an infusion that requires 60 hours to administer and an out-of-pocket cost of up to $34,000. I’m excited that a medication that may be taken at home will be much more far reaching,” she says.
The current recommended dose of Zurzuvae for most patients prescribed the medication is 50 milligrams once daily for 14 days (similar to its administration in clinical trials). Individuals are advised to take Zurzuvae with a meal that includes fats to increase absorption. Dr. Romanoff notes that side effects may include sedation, fatigue, dizziness and headaches. The FDA also notes that if suicidal thoughts and behaviors occur while taking Zurzuvae, it should be discontinued.
Additionally, Dr. Oreck says recent studies on zuranolone exclude pregnant or nursing individuals, so more research is needed to further understand if it’s safe for these groups and how the medication may be transmitted via breast milk.
If you think you or your spouse or partner may be living with PPD, talk to your primary care physician or a mental health care professional like a therapist or psychiatrist. Medication and therapy can be highly effective in alleviating symptoms of PPD, allowing one to better weather and enjoy all the moments of new parenthood.
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