How New Postpartum Depression Treatment Work?
It’s common to experience what’s often referred to as the “baby blues” after giving birth. Your hormone levels go up and down after labor and delivery. These changes can trigger mood swings, anxiety, trouble sleeping, and more. If your symptoms last longer than two weeks, you may have postpartum depression (PPD).
PPD affects around 1 out of every 7 women after giving birth. It’s usually much more intense than those initial baby blues. You may experience excessive crying episodes. You may find yourself withdrawing from friends and family or other social situations. You may even have thoughts of harming yourself or your baby.
Other symptoms include:
- difficulty bonding with your baby
- severe mood swings
- an extreme lack of energy
- difficulty making decisions
- panic attacks
But On Tuesday (March 19), the U.S. Food and Drug Administration (FDA) announced the first-ever approval of a drug specifically meant to treat postpartum depression.
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But how exactly does the drug work, and what makes it different from other medications for depression?
The new drug, brexanolone — which will be sold as Zulresso by Sage Therapeutics, to be given in a health care facility under medical supervision and is delivered intravenously over the course of 60 hours (2.5 days), the FDA said.
This is much quicker than the antidepressants currently used to treat postpartum depression, which take anywhere between two to four weeks to take effect. The drug is also expected to be expensive, costing more than $30,000 before insurance.
Health experts believe the new treatment provides hope for the thousands of women who live with PPD each year.
Brexanolone is “unlike anything else we have currently approved for depression, there are no FDA-approved antidepressants for postpartum depression, so approval of the first medication of its kind is a breakthrough for patients,” said Dr. Kristina Deligiannidis, director of women’s behavioral health at Zucker Hillside Hospital in New York, who was involved with the clinical trials of the drug leading up to its approval.
The drug is a synthetic version of a steroid called allopregnanolone, which people make naturally in their bodies. Allopregnanolone is a breakdown product of the sex hormone progesterone, and is produced in the brain and ovaries, as well as in the placenta during pregnancy.
According to Sage Therapeutics Inc., the company that makes brexanolone. It’s unclear exactly how brexanolone works to treat postpartum depression. But it’s thought that the drug modifies the body’s stress response, which is abnormal in women with postpartum depression. The drug binds to GABA receptors, which play a role in many brain functions.
A different type of treatment
Brexanolone works in a different way than other drugs for depression, which typically don’t bind to GABA receptors, Deligiannidis said. A class of drugs called benzodiazepines, sometimes referred to as tranquilizers, also bind to GABA receptors, but they bind to a different type of GABA receptor than brexanolone and have a different function, she said.
Back in 2016, the FDA ordered a “breakthrough therapy designation” for brexanolone, which essentially expedites the development and review of drugs intended to treat a serious or life-threatening condition.
The drug underwent three clinical trials between 2016 and 2017 to evaluate the efficacy, safety, and pharmacokinetics — or how the body processes the drug. The trials studied 247 women who were randomly selected to receive either brexanolone or a placebo.
All women had given birth within six months of receiving the treatment and were living with moderate to severe symptoms of PPD. The participants couldn’t have bipolar disorder or psychosis, nor could they have had a recent suicide attempt.
The researchers followed the women over 30 days and found that those who received brexanolone showed significant improvements compared to the women who took the placebo.
According to Deligiannidis, after just 60 hours had passed, nearly half of the women receiving brexanolone were in remission and were no longer considered to be clinically depressed.
It’s still unclear how brexanolone works so quickly compared with other drugs for depression, which can take weeks to have an effect, she said.
As doctors prescribe the drug, they’ll get a better understanding of how long the effects last beyond 30 days, Deligiannidis said. But a monthlong period also gives doctors a chance to start other treatments for depression, such as talk therapy, she added.
Because some women who received brexanolone experienced excessive sedation and sudden loss of consciousness, the drug needs to be administered under supervision, the FDA said.
Sage Therapeutics is also working on a similar drug for postpartum depression that can be taken as a pill once a day. That drug is currently in clinical trials and is not yet FDA-approved.
Health experts agree that there’s a lot we need to learn about brexanolone in addition to the new pill being developed.
“While these drugs appear to be novel remedies, more research needs to be done with them concerning if there will be any significant long-term neurological effects, and what effect, if any, will occur with subsequent pregnancies,” said Dr. Kecia Gaither, a double board-certified OB/GYN and maternal fetal medicine physician with NYC Health+Hospitals/Lincoln.