About half a million women in the United States suffer from postpartum depression every year, and on Friday, the Food and Drug Administration authorised the first drug specifically for this disease.
Clinical study results reveal the pill’s antidepressant effects may be seen in as little as three days, far sooner than the two weeks or more it typically take for the full impact of standard antidepressants. Experts in maternal mental health have speculated that this, together with the drug’s short two-week treatment period, might increase treatment uptake.
Perhaps more important than any of the drug’s purported benefits is the fact that it has been approved specifically for postpartum depression. There are other antidepressants that are effective in treating postpartum depression, but the availability of one specifically shown to address it could help reduce the stigma of the condition by emphasising its biological roots and showing that women should not blame themselves for developing it.
The drug, zuranolone, will be sold under the trade name Zurzuvae; it was created by Sage Therapeutics, a Massachusetts firm that works in conjunction with Biogen to manufacture the drug. Sage said it would be accessible when the medicine Enforcement Administration finished its mandatory 90-day study of the medicine because of its effects on the central nervous system. The cost of the tablet has not been disclosed by the manufacturers.
Brexanolone, also created by Sage and sold as Zulresso, is the only other medicine licenced for postpartum depression. However, the 2019 FDA-approved drug brexanolone calls for a 60-hour hospitalisation, comes with risks of unconsciousness, and costs $34,000. To yet, just roughly 1,000 people, according to Sage, have gotten it.
Women’s reproductive mental health programme head at UC San Diego, Dr. Alison Reminick, estimated that 10% of her patient population would be good candidates. Among them would be women who are dealing with depression for the first time. She noted that such people are more likely to acquire bipolar illness. Selective serotonin reuptake inhibitors (S.S.R.Is) like Lexapro and Zoloft are effective, but they may lead to mania in certain people, she warned.
Two company-funded clinical studies involving around 350 participants provided the data submitted to the FDA. After the two-week course, the majority of individuals given Zurzuvae showed clinical response (72% in one experiment, 57% in another), defined as a 50% or more improvement on a conventional depression scale.
Similar improvements in depression were seen in women who received the placebo, a finding typical in investigations of depression therapy. Three days following drug initiation, the group given Zurzuvae showed significantly better improvement than the control group. Patients receiving Zurzuvae were more likely to have a depression score low enough to be deemed in remission 15 days after starting treatment.
The benefit persisted for the full 45 days of follow-up in the studies, long after patients stopped taking the drug. However, a number of specialists in maternal mental health have argued that longer-term data is necessary to assess relapse.
