First pill for postpartum depression to be approved by the FDA

The Food and Drug Administration is expected to decide by Saturday whether to approve the first-ever pill for postpartum depression.

The medicine, called zuranolone, is taken daily for two weeks. IN a couple of clinical trials with women experiencing severe depression after having a baby, the drug improved symptoms — such as anxiety, trouble sleeping, loss of desire, low energy, guilt or social withdrawal — as early as three days after the first pill.

The medicine has been jointly developed by the pharmaceutical companies Biogen and Sage Therapeutics. If approved, it will be the first treatment for postpartum depression that can be taken at home. The only other option available is an intravenous injection which the FDA approved in 2019. It requires patients to stay in a hospital for two and a half days.

Dr. Samantha Meltzer-Brody, director of the University of North Carolina’s Center for Women’s Mood Disorders and an investigator on both zuranolone trials, said the data so far are “incredibly encouraging and very exciting.”

But she cautioned that the trials only followed patients for 45 days.

“We know that it works quickly and that you have a lasting effect until day 45, but what happens after that remains to be seen,” Meltzer-Brody said.

Women who were breastfeeding or had mild or moderate depression were not included in the trials.

“At the moment, we can’t recommend this for people who are breastfeeding until we have more data,” says Dr. Lauren Osborne, vice chair for clinical research in the Department of Obstetrics and Gynecology at Weill Cornell Medicine.

At the same time, the FDA is considering whether zuranolone should be approved for clinical depression, so that the pill can be approved for one or both indications.

Postpartum depression is common among new mothers

About 1 in 8 women report symptoms of postpartum depression after recently giving birth, a report from the Centers for Disease Control and Prevention found.

Overall, mental disorders are an underlying cause of approx 9% of deaths among women during or within a year of pregnancyAccording to the CDC.

Postpartum depression is more intense and lasts longer than the typical worry, sadness or fatigue that many women experience after giving birth. The condition can make it harder for mothers to bond with their babies and can increase the likelihood of developmental delays in infants.

Amy Bingham, a 33-year-old resident of Burlington, North Carolina, began feeling depressed shortly after giving birth to her son, Benjamin, in 2018. With her parents overseas in England and her husband at work, she was left to take care of the baby alone, she said.

“It was very overwhelming. I was very afraid that I wasn’t doing the right thing for my child,” Bingham said.

Bingham signed up for the UNC Chapel Hill zuranolone trial after seeing an ad on Facebook. After five days on the medication, she said, she began to feel less anxious and more in tune with her son’s emotional cues.

“I was able to enjoy my time with him,” Bingham said. “It allowed me to get to know him. I was able to bond with him.”

Bingham said her depression returned after the trial ended.

Osborne said researchers still aren’t sure whether people might need follow-up doses.

Zuranolone is a neuroactive steroid – a synthetic hormone that is synthesized in the brain and helps regulate mood and behavior. The drug works on GABA receptors, chemical messengers thought to play a role in regulating fear, anxiety and stress. Studies have displayed that people with depression have abnormally low GABA levels.

Osborne said the receptors that stimulate the release of GABA change significantly during the postpartum period, in part because the body produces lots of reproductive hormones.

How zuranolone compares to the existing postpartum depression treatment

Zuranolone offers several advantages over the existing treatment for postpartum depression, called Zulresso, according to the experts interviewed.

Although 70% of women see an improvement in their symptoms within 24 hours of receiving the Zulresso injection, Meltzer-Brody said, it takes 60 hours to administer.

The treatment is “not practical, to say the least, but quite transformative,” she said.

Zulresso also carries a risk of excessive sedation or sudden loss of consciousness – side effects that were not observed in trials with zuranolone.

The zuranolone trials also did not find the classic side effects of antidepressants, such as sexual dysfunction, weight gain, sleep disturbances or an increased risk of suicidal thoughts, according to Anita Clayton, the national principal investigator for two zuranolone trials in people with clinical depression.

The main side effects included drowsiness, dizziness, sedation, headache, nausea and diarrhea.

However, for people with mild or moderate postpartum depression, psychotherapy is still the best treatment. Some are prescribed antidepressants, but Meltzer-Brody said zuranolone may be preferable because it seems to improve symptoms more quickly.

“If you asked a new mother who has postpartum depression, ‘Do you want something that can work in days, or would you rather take weeks to months?’ most people really don’t have to think that long,” she said.

The new pill may also be approved for clinical depression

Clayton said she expects the FDA to approve zuranolone for both postpartum and clinical depression.

Six zuranolone trials have focused on patients with clinical depression, and five showed positive results, she said. But in one trial, the drug was no better than placebo in improving symptoms at the 15-day mark. However, it improved symptoms at other times.

“Five out of six were positive, so that’s pretty impressive,” said Clayton, who is chair of psychiatry and neurobehavioral sciences at the University of Virginia School of Medicine.

IN one of the zuranolone trials, 80% of patients who responded to the initial treatment required an additional course of treatment over a one-year period. A small group with persistent symptoms required three, four or five courses.

But Clayton said ending just one depressive episode early can improve a person’s long-term outlook.

“What you want to do is get people into remission and feel normal without symptoms, and then people are more likely to stay healthy for longer,” she said.

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