FDA Grants Approval to Zuranolone, Revolutionary Pill for Postpartum Depression
The Food and Drug Administration announced on Friday that the first oral treatment for postpartum depression has been approved. Zuranolone is a once-daily tablet that Sage Therapeutics and Biogen will market under the brand name Zurzuvae.
Zuranolone is approved for use in adults to treat postpartum depression, an episode of severe depression that can commence after childbirth or the later stages of pregnancy and affects an estimated 15% of women in the weeks or months following childbirth.
In a statement, Dr. Tiffany Farchione, director of the Division of Psychiatry at the FDA’s Center for Drug Evaluation and Research, said, “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”
Prior to this, the only approved treatment for postpartum depression was also manufactured by Sage Therapeutics: brexanolone, marketed as Zulresso and administered via intravenous infusion. In 2019, the FDA authorized it as the first treatment designed specifically for postpartum depression.
Sage and Biogen believe zuranolone functions as a fast-acting steroid that attaches to GABA receptors in the brain, resetting neurotransmitters in depressed patients.
Zuranolone’s label will include a boxed warning instructing patients not to drive or operate machinery for 12 hours after taking the medication. The FDA lists lethargy, vertigo, diarrhea, fatigue, the common cold, and urinary tract infection as the most common adverse effects. There is a possibility of suicidal ideation. According to the FDA, women taking the substance should use contraception to prevent fetal injury.
Before the substance can be sold, the substance Enforcement Administration must complete a 90-day scheduling process, according to the companies.
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Major Depression Treatment Still Awaits Approval
The companies had promoted the once-daily pill, which was intended to be taken for only two weeks, as a prospective new “paradigm” for treating severe depression. They sought FDA approval for the drug as a treatment for both postpartum depression and major depressive disorder.
However, as of Friday, the FDA has only officially approved the drug for postpartum depression.
While physicians are generally permitted to prescribe medications for unapproved “off-label” uses, the absence of an approval prevents drug manufacturers from marketing the tablets for these purposes.
It was unclear at first what issues precluded the FDA from sanctioning the drug for major depressive disorder.
Both Sage Therapeutics and the FDA did not respond promptly to a request for comment.
Both major depressive disorder and postpartum depression have been effectively treated with the medication, according to the drug’s manufacturers.
In a recent clinical trial, researchers found that a 14-day course of zuranolone tablets appeared to help prevent recurrences of depressive episodes in many patients for months, before a second course of the medication may be required.
This is in contrast to the majority of common antidepressants, such as selective serotonin reuptake inhibitors (SSRIs), which take longer to produce results and which many patients end up taking for the rest of their lives.
However, these results followed earlier setbacks for the company in 2019, when it was disclosed that a pivotal Phase 3 study of the treatment failed to demonstrate “a statistically significant reduction” over a placebo in treating depression.
Sage Therapeutics stated at the time that their data revealed that some patients in the study had no detectable drug concentration in their bodies, indicating that they had missed doses and distorted the results.
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Source: CBS News
