Zuranoron relieves the main symptoms of postpartum depression

Zlanorone has proven safe and effective in reducing the symptoms of postpartum depression in Phase III clinical trials.

Patients taking Zlanoron, a clinical trial treatment for depressive disorder, showed a significant improvement in their depressive score on day 15 compared to patients in the placebo group (-17.8 points vs. -13.6 points, respectively). ), Said Christina Deligiannidis, MD, of the Finestein Institute. Medical research in Manhaset, New York, and colleagues.

Significant reduction in Hamilton Depression Rating Scale (HAMD-17) score compared to placebo group, as early as day 3 (difference -2.7, 95% CI -5.1 to -0.3) to day 1 zulanolone group Was observed in. 45 (-4.1, 95% CI -6.7 to -1.4), they write: JAMA Psychiatry..

About three-quarters of women who took Zuranoron had a 50% or greater reduction in their depression score after two weeks of treatment. In addition, 48% were in remission during that period.

“Women with postpartum depression who participated in this study had a rapid decrease in both depression and anxiety symptoms,” said Deligian Nidis. Today’s MedPage..

Deligiannidis added that the study was “the first oral neuroactive steroid tested in women with postpartum depression” and that the drug could be a fast-acting option for patients. Brexanolone (Zulresso) is now available to patients in clinical practice, and patients receive selective serotonin or norepinephrine reuptake inhibitors (SSRI or SNRI) to treat perinatal or postpartum mood disorders. It may be administered. Clinicians may see the results of these standard treatments between 8 and 12 weeks, Deligiannidis said.

She added that Zlanoron’s 14-day course will change the paradigm of how to treat patients in this group. “This study is promising because it is the first step towards a very different way of treating women with postpartum depression,” she said.

“Zuranoron looks very promising and could be the first effective oral treatment with signs of postpartum depression,” said Dr. Cheryl Kingsburg, director of obstetrics and gynecology behavioral medicine at Cleveland University Hospital. Stated.

Kingsburg, who was not involved in this study, Today’s MedPage Brexanolone is available as an IV drip, but via email that Zuranolone is a highly needed oral alternative. “Clinicians are safe and effective in postpartum depression, rapidly reducing the symptoms that patients can tolerate and are as safe and easy to use as current standard treatments for SSRIs and SNRIs with no signs of postpartum depression. Needs treatment, “she said.

Deligiannidis et al. State that about 13.2% of new mothers experience symptoms of postpartum depression. Postpartum depression is one of the most common complications during and after pregnancy, but it is poorly diagnosed and poorly treated.

In 2019, Brexanolone became the first and only drug Approved By the FDA, especially for postpartum depression. Brexanolone is currently under the Risk Assessment and Mitigation Strategy (REMS) protocol and will be administered IV in a clinical setting for 60 hours. Zlanorone has a similar mechanism to this drug, but is designed to be taken orally once daily.

The Deligiannidis group Double-blind randomized trial Evaluate the safety and efficacy of Zuranoron. The trial was conducted at 27 facilities in the United States and was conducted between January 2017 and December 2018. All participants were 18-45 years old, within 6 months of postpartum, and had signs of postpartum depression during the third trimester up to 1 month of postpartum. The HAMD-17 score at baseline was 26 or higher.

Patients who received the intervention took 30 mg of zulanolone once daily, but reduced the dose to 20 mg if the initial dose was unacceptable. The study investigators performed a post-treatment evaluation in an outpatient clinic and followed participants for up to 45 days.

A total of 148 patients completed treatment, 76 in the Zuranolone group and 72 in the placebo group. Of all patients who completed treatment with zulanolone, 3 reduced the dose to 20 mg.

The average age of the patients was 29 years in the Zlanoron group and 27 years in the placebo group. In both groups, more than half of the participants were white and about 40% were black. At baseline, approximately 18% of patients in the Zlanorone group and 21% in the placebo group reported taking stable doses of antidepressants.

On day 15, patients taking Zlanorone experienced remission (OR 2.53, 95% CI 1.24-5.17) or HAMD-17 response (≥50% score reduction; OR 2.63, 95% CI 1.34-5.16). It was more than double the chance of doing it. To the people of the placebo group. The researchers also observed an improvement in overall and maternal function in patients who took Zlanoron.

The most common side effects reported with Zuranoron were drowsiness, headache, dizziness, upper respiratory tract infections, diarrhea, and sedation. One patient in each group experienced a serious adverse event. One patient in the Zuranoron cohort experienced confusion and sedation, and one in the placebo group developed pancreatitis.

Deligiannidis and colleagues acknowledged that the results of the US population may not be generalized at the global level. In addition, the follow-up period ended on day 45, so the sustained effect of treatment beyond this period is unknown.

In further trials, zulanolone will be evaluated at various doses over a long period of time. However, as many women still tolerate the symptoms of postpartum depression without treatment, Deligiannidis said it is important for clinicians to identify patients at risk.

“There are a large number of women who are undetected or untreated,” she said. “We encourage clinicians to screen women for perinatal mood and anxiety disorders.”

Last updated: July 1, 2021