About one in eight girls within the United States experiences postpartum depression after giving start. Soon, there could lastly be a handy, fast-acting treatment to deal with it—if the Food and Drug Administration provides it the inexperienced gentle.

The tablet, known as zuranolone, is taken over the course of 14 days and works to alleviate depressive signs in as quickly as three days. The FDA is predicted to resolve whether or not to approve the drug by August 5. If they do, it will be the primary tablet particularly designed to deal with postpartum melancholy.

“This will be a game changer,” says Jennifer Payne, director of the Reproductive Psychiatry Research Program on the University of Virginia School of Medicine, who treats sufferers with postpartum melancholy and researches the organic mechanisms behind it.

While many individuals expertise short-term temper swings after childbirth—typically known as the “baby blues”—postpartum depression lasts longer and is more severe, affecting a person’s ability to function normally. Symptoms include extreme feelings of sadness, anxiety, panic, and fatigue. Those with postpartum depression may also feel disconnected from their babies and have trouble bonding.

During pregnancy, the hormones estrogen and progesterone increase about 10-fold. A few days after delivery, they plummet to pre-pregnancy levels. This sudden drop is thought to be a major contributing factor to postpartum depression.

Considered a neurosteroid, zuranolone is a synthetic version of allopregnanolone, a naturally occurring byproduct of progesterone. It acts on GABA receptors in the brain—a major signaling pathway that helps regulate stress and mood. GABA calms the nervous system down, and people with major depression and chronic stress have been found to have lower levels of this chemical.

Essentially, zuranolone works by “resetting the neural circuits back to normal functioning, so that the brain can handle stress as it should,” says Kristina Deligiannidis, a psychiatrist on the Feinstein Institutes for Medical Research in New York who led a scientific trial of the treatment.

The examine, revealed final week in The American Journal of Psychiatry, adopted 196 girls with postpartum melancholy for 45 days. Half had been randomized to obtain zuranolone, whereas the opposite half acquired a placebo. After two weeks, 57 p.c of those that took zuranolone skilled important enchancment of their depressive signs in comparison with 38 p.c who acquired a placebo. By the top of the trial, almost 62 p.c of those that obtained zuranolone had been nonetheless experiencing important reduction, in comparison with 54 p.c of the placebo group.

Side results included drowsiness, dizziness, headache, diarrhea, and nausea. The trial was funded by Massachusetts biotech corporations Sage Therapeutics and Biogen. (The drug can be being thought-about by the FDA to deal with main depressive dysfunction extra usually.)

Zuranolone wouldn’t be the primary drug accredited particularly for postpartum melancholy, though it will be the primary tablet. In 2019, the FDA approved brexanolone, bought below the model identify Zulresso. Also manufactured by Sage Therapeutics, the drug prices $34,000. But it isn’t extensively used, partly as a result of it’s given as an IV infusion over two and a half days, which means sufferers should keep within the hospital. There’s additionally a danger that customers can abruptly lose consciousness because it’s being administered, so it’s solely accessible at sure certified well being care amenities. (Notably, no individuals in trials of zuranolone have skilled lack of consciousness, which is essential, for the reason that very best remedy could be one which may very well be taken at residence.)