Food and Drug Administration will decide on Saturday whether or not to approve the world’s first pill to treat postpartum depression.
The drug zuranolone is taken twice daily for two consecutive weeks. The drug was effective as soon as three days following the first pill in two clinical trials that involved women with severe depression.
Biogen and Sage Therapeutics developed the medication jointly. It will be the first home-based treatment for postpartum depressive disorder. intravenous injection is the only other option. The FDA approved it in 2019. The FDA approved this intravenous injection in 2019.
Dr. Samantha Meltzer Brody, Director of the University of North Carolina’s Center for Women’s Mood Disorders, and investigator in both zuranolone studies, said that the results so far have been “incredibly encouraging and exciting.”
She cautioned, however, that only 45 days of patient follow-up was included in the trial.
Meltzer Brody: “We know it works fast and you get a lasting effect up to 45 days, but after that we don’t know what will happen.”
The trials excluded women who were breastfeeding or mild to moderately depressed.
We don’t have enough data to recommend it for women who are nursing, said Dr. Lauren Osborne. She is vice chair of Clinical Research in the Department of Obstetrics and Gynecology, Weill Cornell Medical.
The FDA is also considering whether zuranolone should be approved to treat clinical depression. Therefore, the pill may be approved in one or both cases.
Postpartum depression affects many new mothers
A report by the Centers for Disease Control and Prevention revealed that around 1 in 8 women experience symptoms of postpartum depressive disorder after giving birth.
According to the CDC, mental disorders are responsible for around 9% (or fewer) of all deaths in women who were pregnant or died within a year of their delivery.
The postpartum depression that women often experience is much more severe and lasts longer. This condition can affect the bonding between mothers and their infants, increasing the risk of development delays in babies.
Amy Bingham, 33, of Burlington in North Carolina, began to feel depressed soon after she gave birth to Benjamin. She said that her parents were in England, and her husband was at work. This left her to take care of the baby on her own.
It was overwhelming. Bingham says, “I was afraid that I wasn’t making the right decision for my child.”
Bingham signed up for the zuanolone study at UNC Chapel Hill after seeing a Facebook advertisement. She said that after five days of taking the medication, her anxiety levels decreased and she became more aware of her son’s emotions.
Bingham stated, “I enjoyed my time with him.” It allowed me to learn more about him. I was able bond with him.
Bingham says that her depression returned to Bingham after the trial.
Osborne says that researchers are still unsure if people need to receive additional doses.
Zuranolone, a neuroactive hormone synthesized by the brain to regulate mood and behaviour, is a steroid. The drug works on GABA receptors. These chemical messengers are thought to regulate fear, anxiety, and stress. Studies show that depression patients have abnormally low GABA.
Osborne stated that the receptors which stimulate the release GABA are significantly altered during the postpartum phase, partly because the body produces a lot of reproductive hormones.
How does zuranolone compare to other postpartum depression treatments?
According to experts interviewed, Zuranolone has several advantages over Zulresso (the existing treatment for postpartum depressive disorder).
Meltzer Brody stated that although 70% of women experience improvement within 24 hours after receiving Zulresso, the injection takes 60 hours.
She said that the treatment was “not convenient at all, but quite transformative.”
Zulresso can also cause excessive sedation, or a sudden loss of consciousness. These side effects were not seen in the trials with zuranolone.
Anita Clayton is the principal investigator of two trials of zuranolone in clinical depression patients.
Headache, nausea, diarrhea, and dizziness were the main side effects.
Psychotherapy remains the treatment of choice for people with mild to moderate postpartum depressive disorders. Meltzer Brody says that while some people are prescribed antidepressants to treat their symptoms, zuranolone is a better option because it appears to work faster.
She said that most women don’t need to spend much time thinking about it.
The new drug may also be approved for clinical depression
Clayton expects that the FDA will approve zuanolone as a treatment for postpartum depression and clinical depression.
She said that five of the six trials on clinical depression patients showed positive results. In one trial the drug did not improve symptoms any more than a placebo after 15 days. However, it did improve symptoms in other time periods.
“Five of the six results were positive. That’s pretty impressive,” Clayton said. Clayton is chair of psychiatry, neurobehavioral science and psychiatry at University of Virginia School of Medicine.
In a zuranolone trial, 80 percent of patients who responded well to the first treatment needed an additional course of treatment over the course of a year. A small group of patients with persistent symptoms needed three, four or even five courses.
Clayton, however, said that even ending one episode of depression early can have a positive impact on a person’s future prospects.
She said that if you can get patients to remission, feeling normal and free of symptoms, they are more likely to stay healthy for a long time.