In a press release issued by Sage Therapeutics, the company said Zulresso will be available towards the end of June, following scheduling by the US Drug Enforcement Administration, which should take place within 90 days of approval.
Brexanolone is a synthetic form of the compound allopregnanolone which is a hormone produced by the female hormone progesterone in the brain. According to Vox, experts believe it works by replenishing hormones thought to cause postpartum depression.
"Post-partum depression is a serious condition that, when severe, can be life-threatening".
Unlike conventional antidepressants, which can take weeks to kick in, the single infusion starts working within 2-3 days of dosing and can lift women quickly out of the sadness, anxiety, irritability, and social withdrawal that can accompany PPD. "With postpartum depression, having an illness that is most likely linked to a hormonal trigger and can be treated with a hormonal therapy like [Zulresso] goes a long way toward decreasing stigma, increasing acceptance of the diagnosis, and encouraging women to seek help".
The condition "can also interfere with the maternal-infant bond", added Farchione, who is acting director of the Division of Psychiatry Products in the agency's Center for Drug Evaluation and Research.
The FDA approved intravenous infusion of the drug brexanolone, which will be sold as Zulresso.
The clinical trials "involved 247 women randomly selected to receive a placebo or brexanolone - a relatively small number of participants, compared to many other medical trials". Symptoms were improved at the end of the first infusion, and Zulresso remained effective through to a 30-day follow up. The primary measure in the study was the mean change from baseline in depressive symptoms as measured by a depression rating scale.
"Today's approval of Zulresso represents a game-changing approach to treating PPD", said Dr. Samantha Meltzer Brody, director of the Perinatal Psychiatry Program, UNC Center for Women's Mood Disorders and primary investigator of the Zulresso clinical trials.
In spite of its promise, brexanolone does have its drawbacks.
Deligiannidis said the drug was largely safe, with headache (about 16 percent of patients), dizziness (about 14 percent) and sleepiness (nearly 11 percent) being the most common side effects. The full rate is without the cost of the hospital stay for administering it.