The FDA approves the first drug specifically for the treatment of postpartum depression, a mental illness that impacts 1 in 9 new mothers
For the first time in history, the US Food and Drug Administration has approved a drug specifically indicated for the treatment of postpartum depression, which experts say offers new hope to women and physicians.
On Tuesday, the FDA announced the approval of an intravenous infusion of the drug brexanolone, which will be sold as Zulresso. It has been shown in clinical trials to work within hours to treat the symptoms of postpartum depression, a serious mental illness that impacts 1 in 9 new mothers after childbirth. The treatment is administered as a single 60-hour IV drip and was found to have mild side effects, such as headache, dizziness or excessive sleepiness.
Millennials and postpartum depression 02:08Overall, at 60 hours, about 75% of women who received brexanolone were at least 50% improved in their symptoms and about half of women who received brexanolone were no longer clinically depressed, Deligiannidis said.Among the patients who had a response at 60 hours, 94% did not relapse at the 30-day followup.The most common side effects included headache among 15.7% of patients; dizziness among 13.6%; and somnolence or excessive sleepiness among 10.
The clinical data supporting the effectiveness of brexanolone in helping women recover from postpartum depression sheds new light on the neurobiology of the illness, as well as depression during other life periods, said Catherine Monk, professor of medical psychology in obstetrics and gynecology and psychiatry at Columbia University Irving Medical Center and director of research in the women's program in psychiatry at NewYork-Presbyterian/Columbia University Irving Medical Center in New...
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