The FDA is set to approve the first-ever postpartum depression medication this week
The first-ever postpartum depression medication is anticipated to be approved by the Food and Drug Administration by Saturday.
For two weeks, the drug zuranolone must be taken every day. In two clinical trials including women who suffered from severe postpartum depression, the medication reduced symptoms as early as three days following the first tablet, including anxiety, insomnia issues, loss of enjoyment, low energy, guilt, and social withdrawal.
Pharmaceutical firms Sage Therapeutics and Biogen collaborated to create the drug. It will be the first postpartum depression medication that may be used at home if it is authorised. The FDA approved an intravenous injection as the sole additional treatment in 2019. Patients must spend two and a half days in the hospital.
The results thus far are “incredibly encouraging and very exciting,” according to Dr. Samantha Meltzer-Brody, director of the University of North Carolina Centre for Women’s Mood Disorders and an investigator on both zuranolone trials.
She did note, however, that patients were only tracked for 45 days in the trials.
Dr. Lauren Osborne, vice chair of clinical research in the Department of Obstetrics and Gynaecology at Weill Cornell Medicine, stated that at this time, “until we have more data, we cannot recommend this for people who are breastfeeding.”
Zuranolone may be approved for one or both indications because the FDA is also debating whether to approve it for treating clinical depression.
Among new mothers, postpartum depression is prevalent.
According to a Centres for Disease Control and Prevention survey, 1 in 8 women who have just given birth report experiencing postpartum depression symptoms.
According to the CDC, roughly 9% of deaths among pregnant women or those occurring within a year after giving birth have a mental health problem as their primary cause.
Compared to the ordinary worry, sadness, or fatigue that many women experience after giving birth, postpartum depression is more severe and lasts longer. Infants with the syndrome may be more likely to experience developmental delays and may find it more difficult to bond with their moms.
After giving birth to her baby, Benjamin, in 2018, Burlington, North Carolina resident Amy Bingham, 33, began experiencing depression. She said that she was left to take care of the infant by herself because her husband was at work and her parents were in England.
It was quite intimidating. I was terrified that I wasn’t providing for my child in the best interests,” Bingham said.
Bingham signed up for the zuranolone trial at UNC Chapel Hill after seeing an advertisement there. She claimed that after taking the drug for five days, she began to feel less worried and to be more sensitive to her son’s emotional cues.
I was able to take pleasure in our time together, Bingham stated. It helped me get to know him better. I could connect with him.
However, Bingham claimed that after the trial was over, her sadness reappeared.
Osborne stated that it’s yet unclear whether patients require additional doses.
Zuranolone is a neuroactive steroid, or synthetic hormone, produced in the brain that aids in mood and behaviour regulation. The medication affects GABA receptors, which are known to be involved in the control of stress, anxiety, and fear. According to studies, GABA levels in depressed individuals are abnormally low.
According to Osborne, the body produces a lot of reproductive hormones during the postpartum period, which causes a considerable alteration in the receptors that promote GABA release.
How Zuranolone stacks up against the current postpartum depression therapies
According to the specialists surveyed, Zuranolone has a number of benefits over the already used drug Zulresso for postpartum depression.
Meltzer-Brody stated that although 70% of women have symptom alleviation after 24 hours of having the Zulresso injection, the procedure takes 60 hours.
“Not convenient to say the least, but pretty transformative,” she said of the procedure.
A negative effect of zulresso that was not seen in zuranolone studies is severe sedation or an abrupt loss of consciousness.
Anita Clayton, the national principal investigator for two zuranolone trials in people with clinical depression, claims that neither the weight gain, sleep disturbances, sexual dysfunction, or increased risk of suicidal thoughts were discovered in the zuranolone studies.
Drowsiness, dizziness, sedation, headache, nausea, and diarrhoea were the predominant adverse reactions.
However, psychotherapy is still the preferred course of treatment for women who have mild to moderate postpartum depression. Antidepressants are frequently administered, however Meltzer-Brody suggested that zuranolone would be preferred because it appears to alleviate symptoms more quickly.
“If you were to ask any postpartum depressed new mother, “Would you choose anything that can work in days, or would you prefer something that can take weeks to months?” Most individuals don’t have to consider that for very long, according to her.
The new drug might also be authorised for treating serious depression.
Clayton stated that she anticipates the FDA will approve zuranolone for both clinical depression and postpartum.
“What you want to do is get people to remission and feeling normal, without symptoms, and then it’s more likely that people will stay well for a longer period of time,” the expert advised.
