Postpartum depression is the most common complication of pregnancy, affecting up to one in seven women who have recently given birth. On Tuesday, as Elizabeth Chuck and Lauren Dunn of NBC News report, the F.D.A. announced that it has approved the first-ever drug specifically targeted to this condition, offering a promising and fast-acting new treatment option for new mothers who struggle with depression.
The drug is called brexanolone (its brand name is Zulresso) and it was developed by the Massachusetts-based company Sage Therapeutics. Crucially, brexanolone addresses the hormonal changes that women experience during pregnancy and after birth; it contains a synthetic form of the hormone allopregnanolone, a derivative of progesterone that rises during pregnancy and swiftly drops after a baby is born. Postpartum depression does not have a single cause, but dramatically fluctuating hormones are thought to play a role, triggering chemical reactions in the brain that can lead to mood swings.
For some women who suffer from the condition, postpartum depression is debilitating, even life-threatening. It is distinct from the “baby blues,” common and typically short-lived symptoms among new mothers that include sadness, irritability and difficulty sleeping. According to the Mayo Clinic, signs of postpartum depression “are more intense and last longer,” and can include severe mood swings, excessive crying, loss of appetite and difficulty bonding with the new baby. Some women “may experience thoughts about harming themselves or harming their child,” Tiffany Farchione, acting director of the Division of Psychiatry Products in the F.D.A.’s Center for Drug Evaluation and Research, said in a statement announcing the new treatment.
Until now, women who were diagnosed with postpartum depression were given the same antidepressants as the general population, which can take between two and four weeks to start working—a long time for women who may be struggling to provide the care and nurturing that their babies need during an important period in their development. Brexanolone, by contrast, starts working within 48 hours, according to Pam Belluck of the New York Times.
The drug is administered intravenously over a period of 60 hours. It was tested in three clinical trials involving 247 women, who were randomly selected to receive either an infusion of brexanolone or a placebo. All of the women had given birth within six months, and were experiencing either moderate or severe postpartum depression. Symptoms improved in women receiving both the drug and the placebo—“a phenomenon common in studies of depression treatments,” Belluck notes—but more women in the brexanolone reported an improvement of symptoms, and that improvement was more significant than amongst the women of the placebo group.
Symptoms were evaluated through the Hamilton Depression Rating Scale, a widely used assessment tool. A score of between zero and seven is considered to be within “normal range,” or without depressive symptoms, while a score of more than 24 is indicative of severe depression. In one of the studies, women began the trial with scores of around 28; after receiving the infusion, the placebo group’s average score fell to 14, while the brexanolone group’s scores dropped to an average of nine or 10. Twice as many women in the brexanolone group ranked seven or less on the scale.
The benefits of brexanolone persisted for 30 days. There were anecdotal reports of improvements lasting longer than that, but scientists need “more data to understand what happens in a larger population after 30 days,” Samantha Meltzer-Brody director of the perinatal psychiatry program at the University of North Carolina at Chapel Hill and principal investigator of the studies, tells Belluck.
In spite of its promise, brexanolone does have its drawbacks. It has to be administered in a medical facility—not only because it is given intravenously, but also because patients need to be monitored for adverse side effects. The most common ones observed in the clinical trials were drowsiness and dizziness, but some women also experienced “excessive sedation” and “sudden loss of consciousness,” which pose a risk of serious harm, the F.D.A. says.
The treatment is also expensive; it can cost between $20,000 and $35,000, not including the cost of the hospital stay. Sage Therapeutics officials say they expect insurers will cover the drug, but at the moment it is “probably most appropriate for women with moderate to more severe symptoms who are struggling to function at home, not able to take good care of themselves or their children,” Lucy Puryear, medical director of The Women’s Place, Center for Reproductive Psychiatry at Texas Children’s Pavilion for Women, tells STAT’s Adam Feuerstein.
Sage Therapeutics is currently developing another postpartum treatment, which works in a similar way to brexanolone but can be taken in pill form. That treatment has shown promise in clinical trials, but is still in the experimental phase. For now, medical experts say the F.D.A.’s approval of brexanolone represents a huge step forward in the treatment of a significant medical condition that is still attached to stigma; more than half of women who develop postpartum depression do not seek treatment, due to embarrassment or fears that they will be separated from their babies.
“It does women a service because it really brings attention to a major medical problem and provides legitimacy, and hopefully will encourage people, whether they use this medication or not, to seek and obtain treatment,” Kimberly Yonkers, professor of psychiatry, epidemiology and obstetrics, gynecology and reproductive sciences at the Yale School of Medicine, tells NBC’s Chuck and Dunn. “We’re all thrilled about that.”