By Brooke Steinberg uly 31, 2023 8:57 am Updated

Zuranolone is now being evaluated by the Food and Drug Administration, and a decision is expected on Aug. 5.Feinstein Institutes

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A first-of-its-kind pill for postpartum depression had promising results in recent trials, and could be approved as soon as next week.

A new study published in the American Journal of Psychiatry showed the pill led to positive effects on depression symptoms and was “generally well tolerated.”

“Postpartum depression is underrecognized, undertreated and disruptive for those who live with the condition. We collaborate with researchers around the world in an effort to develop more rapid and effective therapies for the many women who need support,” Dr. Kristina Deligiannidis said in a release from the Feinstein Institutes for Medical Research at Northwell Health.

“We have been working on neuroactive steroid research in PPD for nearly 15 years. The SKYLARK study follows previous successful clinical trials, and publishing its results is a pinnacle moment in treating postpartum depression,” continued Deligiannidis, the trial’s principal investigator, lead author of the paper and director of Women’s Behavioral Health at Zucker Hillside Hospital in Queens. 

The medication, called zuranolone, is an antidepressant that is only taken for two weeks and is in a class of drugs that target GABA receptors — which control signaling in the central nervous system — in the brain using a substance called neurosteroid. 

Zuranolone is now being evaluated by the Food and Drug Administration, and a decision is expected on Aug. 5.

Dr. Kristina M. Deligiannidis is the trial’s principal investigator, lead author of the paper and director of Women’s Behavioral Health at Zucker Hillside Hospital in Queens.Feinstein Institutes

The study — funded by pharmaceutical partners Sage Therapeutics and Biogen — examined 196 mothers experiencing postpartum depression who were split into two groups, half taking zuranolone and half on a placebo pill, for two weeks.

All mothers had positive developments in their depression systems on Day 15, but those taking the real medication had significantly better results. The improvements were still reported four and six weeks later.

Only a small number of participants experienced side effects such as dizziness and sleepiness. Long-term effects are the biggest unknown about the pill, according to the study authors, and it’s unclear if it will have any effect on breastfeeding.

Zuranolone is an antidepressant that is only taken for two weeks and is in a class of drugs that target GABA receptors in the brain using a neurosteroid. Feinstein Institutes

The 14-day neuroactive steroid pill ultimately “showed rapid, clinically meaningful improvements in depressive symptoms at measured time points,” according to the release.

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First pill for postpartum depression could be approved by August: FDA

If approved, zuranolone would be the first ever pill approved explicitly for postpartum depression. The only other drug currently available to treat postpartum depression is Zulresso, which is administered through an IV continuously for 60 hours.

“These clinical trial results are evidence that years of perseverance and dedication lead to significant advances in medicine,” Dr. Kevin J. Tracey, president and CEO of the Feinstein Institutes and Karches Family Distinguished Chair in Medical Research, said in the release.

Zuranolone is designed to rebalance brain networks responsible for mood, arousal, behavior and cognition. The fast-acting pill would be taken once a day for two weeks.

Depression causes the neurotransmitters GABA and glutamate to be thrown off balance, which in turn affects neuron activity. Treatments for depression typically focus on boosting serotonin levels, but research is starting to show that the GABA receptors may be as effective.

Around one in seven women experience PPD, according to the National Institutes of Health.

Postpartum depression may be mistaken for “baby blues” at first — which only lasts a few days to a week after the baby is born — but the symptoms of PPD are more severe and last longer.11What do you think? Post a comment.

Symptoms typically develop within the first few weeks after giving birth, but could also begin during pregnancy or even up to a year after birth, according to the Mayo Clinic.

Those symptoms can include crying too much, difficulty bonding with the baby, withdrawing from friends and family, loss of interest in activities you enjoy, severe anxiety and panic attacks