On March 19, the FDA officially approved the first-ever drug that specifically treats postpartum depression. "It's first time that a drug has been specifically approved to treat postpartum depression, providing an important new treatment option", said Tiffany Farchione from the 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.
The new treatment, while a step forward for new mothers with postpartum depression, is not without risks. In some cases, postpartum depression comes with suicidal thoughts, cognitive problems and "feelings of worthlessness or guilt", the agency said.
"Overall, 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", a researcher involved in two of the drug's clinical trials tells Howard.
Zulresso is the first product specifically indicated for postpartum depression PPD, which can start during pregnancy or any time up to a year after the baby's birth, and affects an estimated 400,000 women in the USA each year.
Zulresso will only be available through a restricted program because of concerns about risks including excessive sedation or sudden loss of consciousness during administration.
Sage Therapeutics told the Times that insurance companies are now evaluating Zulresso, and the company expects insurers will cover the treatment. Mothers without extra home support and low-income mothers are often particularly prone to postpartum depression. "Women may experience thoughts about harming themselves or harming their child, as well as hinder development of a maternal-infant bond", the press release reads. Brexanolone injection 90 μg/kg/hr was administered to 102 women with moderate or severe PPD who also were evaluated throughout the infusion, after the infusion stopped and then periodically for up to 30 days. "It's not just the mother who suffers when there's postpartum depression". For some women with severe depression, antidepressants or psychotherapy have little effect. Symptoms typically start within a few days, weeks or months of having a baby, though signs can start during pregnancy.
It's also pricey, coming in at $34,000 per infusion - and costs even more after factoring in the two-day medical center stay.
"We think this is a novel mechanism that's not been explored before", Sage Chief Executive Jeff Jonas tells Market Watch.
The most common adverse reactions reported by patients treated with Zulresso in clinical trials, the FDA said, included sleepiness, dry mouth, loss of consciousness and flushing.
In 2016, Zulresso was also granted Breakthrough Therapy Designation status, underscoring the significant unmet need in women with PPD.