Highwaystarz-Photography/iStockBY: DR. LINDA DROZDOWICZ
(NEW YORK) — For most mothers a new baby is the most wonderful thing in the world. But for one in nine new mothers, that joy can be rapidly diminished by the crippling menace of postpartum depression (PPD).
Zulresso (brexanolone), a new medication from Sage Therapeutics, may help. The Food and Drug Administration on Tuesday approved the first medication specifically for PPD and the company anticipates it will be available for use under prescription and strict supervision as early as June.
PPD is more than your run of the mill “baby blues.” Symptoms of PPD may include depressed mood, difficulty bonding with your baby, intense anger or anxiety, fear that you’re not a good mother and thoughts of harming yourself or the baby, among other things.
Current treatment can include talk therapy or antidepressants, according to the National Institutes of Health. While a number of antidepressants may be helpful for PPD, they can take weeks to work.
Sage Therapeutics Chief Medical Officer Steve Kanes told ABC News that his company’s medication will be a quicker fix: women with PPD will get a single, 60-hour intravenous (IV) infusion of Zulresso at a local health care facility.
The results in Phase III trials of the drug have been positive.
“It works over and over and over. There have been no failed results,” said Kanes.
Of the 130 people who received brexanolone in the Phase III trials, five became excessively drowsy. Two women in the trials had serious adverse events, such as loss of consciousness and passing out, that were treatment related.
“Because of the potential for near loss of consciousness or loss of consciousness, the FDA in November publicly stated it would like to administer a REMS program for Zulresso,” Dr. Kristina Deligiannidis, the director of Women’s Behavioral Health at Zucker Hillside Hospital in Glen Oaks, New York, told ABC News. Deligiannidis was involved in Phase II and Phase III of the clinical trials.
According to the FDA, REMS is a drug safety program that can be required for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.
Nicole Cirino, a psychiatrist who specializes in pregnant and postpartum women and the director of the division of Women’s Mental Health and Wellness at Oregon Health & Science University, worries about initial access to the Zulresso medication.
“I think it’s a huge deal and I have very little concern about safety,” Cirino, who was not affiliated with the study, told ABC News. “Logistics and access will be the bigger issue. It’s a psychiatric medication requiring an inpatient facility like an obstetrical or general hospital floor, and that is expensive, so insurance companies will put up barriers.”
Zulresso could cost as much as $20,000 $35,000 per treatment.
As for being hooked up to an IV for nearly three days, Cirino said that should not deter some women.
“I think a lot of women are concerned about having to take a daily antidepressant that doesn’t work for three to five weeks, so this might appeal to some women in that it has a fast response,” she said. “The placebo response in this trial was pretty high. For a mom to come in and get that attention and help with her child over 60 hours with a benefit at the end is OK.”
Zulresso is different from most antidepressants people use, both in the way it’s administered and in the way that it works. Instead of targeting serotonin, it is a progesterone metabolite that works through the GABA receptors in your brain.
Stephanie Hathaway, a mother of two who participated in a brexanolone trial as a patient, said she experienced immediate results from the medication.
“It was a painless experience,” she told ABC News. “I did things I hadn’t done in six months [of PPD]. I called my husband and he said, ‘I haven’t heard the ‘you’ in your voice in so long.’”
Linda Drozdowicz, M.D., is a fellow in child and adolescent psychiatry at Yale Child Study Center and member of the ABC News Medical Unit.
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