Why the FDA’s approval of the first oral treatment for postpartum depression is significant
What’s New: On August 4th, the FDA approved the first oral treatment for postpartum depression, Zuranolone.
The new medication works differently than traditional classes of antidepressants. Zuranolone is similar to a naturally occurring substance in the body called allopregnanolone, a neuroactive steroid that is a metabolite of the hormone progesterone. Allopregnanolone levels can rise dramatically during pregnancy and then abruptly drop after childbirth, potentially contributing to postpartum depression.
Why it Matters: Treatment options for depression haven’t improved much since the “Prozac boom” of the 1980s and 1990s. By 1990, Prozac was the most widely prescribed drug in North America, and in 1994, it was the second biggest-selling drug in the world. Many different versions of SSRIs, SNRIs, and other drugs targeting the monoaminergic system have been developed since. Despite their commercial and clinical success, these drugs leave much to be desired: the onset of action is slow (taking 1-2 months usually), many patients are refractory to the treatment, and side effects are numerous.
Postpartum depression (PPD) is a common condition – it affects as many as 1 in 7 new mothers. PPD is a serious and potentially life-threatening condition for both the mother and the child. Short and long-term impacts on the physical and mental development of children of mothers with PPD symptoms may persist even into adulthood.
Before the FDA approved Zuranolone, the only postpartum depression treatment on the market (approved in 2019) was a 60-hour IV drip formula that made the drug inaccessible to many due to the extended stay in a clinic required to deliver it.
The Bottom Line: Zuranolone is a much-needed treatment option for the approximately 400,000 mothers per year who experience PPD. This is a forerunner in many more developments to come as a new wave of treatment options is being tested. In 2019, the FDA approved S-ketamine for treatment-resistant depression. The approval of dextromethorphan/bupropion in 2022 has provided the opportunity for a much faster onset of action than traditional treatments. Finally, new research using psilocybin (yes, the “magic mushrooms”) has recently shown some promising clinical data.
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