An Affordable Medication for Postpartum Depression?

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An Affordable Medication for Postpartum Depression?

Jim Windell

             Postpartum depression is a serious disorder that affects as many as one in nine women after giving birth. Although it is a common mood disorder, it often puts both a mother and her newborn at risk. Among the risks of postpartum depression is the inability of the mother to bond with her baby, feelings of sadness or anxiety, and, in severe cases, thoughts of suicide or harming the child. And postpartum suicide is the second-leading cause of maternal postpartum mortality.

            While various drugs – often antidepressants such as Prozac and Zoloft – have been used for years to treat postpartum depression, in 2019 brexanolone (branded as Zulresso) was announced as the first drug specifically meant to treat postpartum depression. Brexanolone provides a synthetic source of allopregnanolone – a neurosteroid that decreases after childbirth. Brexanolone was touted as having advantages over the usual antidepressants because those drugs often take several weeks to start working and brexanolone began almost immediately. However, concerns raised included logistical challenges – because it was administered intravenously necessitating several days in the hospital – and its $34,000 price tag.

            It was recently announced that an oral medication called zuranolone, that acts on similar receptors as brexanolone, may soon be available. Both zuranolone and brexanolone are manufactured by Sage Therapeutics.

            Kristina Deligiannidis, M.D., an associate professor at the Institute of Behavioral Science at the Feinstein Institutes for Medical Research in Manhasset, N.Y., and principal academic investigator in a recent study, said that a phase 3 trial revealed that women who took zuranolone, a once-daily medication, for two weeks experienced rapid and sustained improvements of postpartum depression and anxiety compared with those taking placebo.

           “For women with severe postpartum depression and suicidal ideation who require hospitalization, brexanolone would be a logical choice,” said Dr. Deligiannidis. “But if we could offer a similar medication in an [oral] form, we could greatly expand the benefit for ambulatory patients.” Deligiannidis has received grants and consulting fees from Sage Therapeutics.

           The phase 3 trial involved 153 women ages 18 to 45 who had given birth in the past six months. All of the participants had been diagnosed with a major depressive episode without psychosis that began between the third trimester of pregnancy and four weeks postdelivery. The participants randomly received 30 mg of zuranolone daily or matching placebo pills for two weeks. These women were then monitored for one month after they stopped taking zuranolone or placebo. Assessments of maternal depression, anxiety, and overall functioning were taken at days 3, 8, 15, 21, and 45. The primary outcome was change in depressive symptoms from baseline to day 15, as measured using the 17-item Hamilton Rating Scale for Depression (HAMD-17).

           By day 15, HAMD-17 scores in women receiving zuranolone fell by 17.8 points compared with 13.6 points in the placebo group—a difference that the authors noted was statistically significant. Noticeable differences in HAMD-17 scores between women taking zuranolone versus placebo were evident at day 3 and remained throughout the trial. At day 45—one month after the women had stopped taking either zuranolone or placebo—53% of the women in the zuranolone group were in remission (defined as a HAMD-17 score of 7 or less) compared with 30% of women in the placebo group.

           “These improvements in patient anxiety were rather stunning and meaningful given how often symptoms of depression and anxiety overlap in postpartum illness,” Deligiannidis said.

           She also pointed out that zuranolone was also associated with strong improvements in measures of maternal functioning, including how well mothers felt they were bonding with their babies and were meeting their self-care needs. “These measures were important to look at because they show that the symptom improvements are related to meaningful changes in these mother’s lives,” she said.

           Zuranolene has side effects and the most common side effects included drowsiness, headache, and dizziness, although these effects were mostly mild or moderate in severity. It is important to note that no women experienced a loss of consciousness, which has been associated with brexanolone infusions. There was also no indication of any withdrawal symptoms after the women had stopped taking zuranolone.

           To read more, look for this article:

Deligiannidis, K.M., Meltzer-Brody, S., Gunduz-Bruce, H., Doherty, J., Jonas, J., Li, S., Sankoh, A.J., Silber, C., Campbell, A.D., Werneburg, B., Kanes, S.J. & Lasser, R. (2021). Effect of Zuranolone vs Placebo in Postpartum Depression: A Randomized Clinical Trial.  JAMA Psychiatry, 78(9), 951-959. doi:10.1001/jamapsychiatry.2021.1559




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