On Tuesday, the U.S. Food and Drug Administration (FDA)
The new drug, brexanolone — which will be sold as Zulresso by Sage Therapeutics — is administered intravenously over the course of 60 hours and provides immediate relief from depressive symptoms, typically within 48 hours.
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.
Currently, approximately one in seven U.S. women experience depression after giving birth, which disrupts the natural bonding process between mother and child, along with the psychological growth of the baby.
“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, a researcher involved in the drug’s clinical trials and the director of Women’s Behavioral Health at Zucker Hillside Hospital in Manhasset, New York.
Back in 2016, the FDA ordered a “
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.
Women who undergo the new treatment must do so from a supervised healthcare center due to the risks and side effects observed in the clinical studies.
Some women may experience dizziness, headaches, or nausea, said Deligiannidis. Others may experience excessive sedation or loss of consciousness.
Furthermore, it may require patients to hold off on breastfeeding during the infusion to avoid feeding the baby contaminated breast milk. So far, though, it looks like only small amounts of the medication reach the breast milk.
“Due to possibly needing to separate the mother and child, this would likely not be a first-line drug for postpartum depression,” Dr. Jennifer Wu, a board-certified obstetrician-gynecologist with Lenox Hill Hospital NYC, predicts.
For now, Wu believes first-line treatment should be counseling and SSRIs — or traditional antidepressants.
That being said, this new treatment may be a good option for those who experience more severe PPD and have failed to respond to SSRIs, she added.
But Zulresso won’t be cheap.
According to Sage Therapeutics, the drug will likely go for about $7,450 a vial, which amounts to approximately $34,000 before discounts or insurance. This excludes the costs that come with staying in a medical center for a couple of days.
The drug is expected to be available June 2019.
Our brains contain a network of receptors — called GABA receptors — that are responsible for the communication between brain cells. During pregnancy, our hormone levels, namely that of progesterone, fluctuate causing a decrease in GABA receptor activity.
After birth, in the postpartum period, hormone levels decline which causes those GABA receptors to turn back on.
“The GABA receptors in effect turn on again — they rebound — but to a great extent, they become ‘hyperactive’ so to speak, leading to depressive symptoms,” explained Dr. Kecia Gaither, a double board-certified OB/GYN and maternal fetal medicine physician with NYC Health+Hospitals/Lincoln.
Brexanolone, which is a synthetic compound made from progesterone, acts to correct the hyperactive GABA receptors and, ultimately, reduce depressive symptoms, said Gaither.
Scientists with Sage Therapeutics are working on developing another drug — currently called SAGE-217 — which can be taken orally, that also acts on the GABA receptors.
Researchers are optimistic about the experimental pill. The results of early clinical studies, which were released January 2019, suggest that the medication also has the potential to quickly and significantly reduce depressive symptoms in women with PPD.
Sage is continuing to run trials, and if approved, the pill would likely be much more accessible and affordable to people with PPD.
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,” Gaither said.
Researchers hope to eventually understand if and when depressive symptoms will resume, if they’ll be as intense as they were prior to treatment, and exactly how soon following delivery the drug needs to be administered.
That being said, these new treatments are a light rising on the horizon, said Gaither.
Postpartum depression has plagued many women throughout the ages — it’s possible physicians have found a better way to treat the condition.
The FDA approved the first drug developed to treat postpartum depression Tuesday.
The treatment, which is to be delivered intravenously over 60 hours, gives hope to the thousands of women who live with postpartum depression each year.
The drug is expected to be expensive, costing more than $30,000 for a full session.