New Analyses Strengthen Efficacy, Safety of Zuranolone for Depression

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Eleven new analyses on zuranolone, an investigational, oral, once-daily, 14-day treatment in clinical development for adult patients with major depressive disorder (MDD) and postpartum depression, indicate the potential of the medication to improve the symptoms of depression. These data were presented at the 2022 Psych Congress in New Orleans.

Zuranolone is a neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). The medication acts as a major part of the inhibiting signaling pathway of the brain and central nervous system and contributes to regulating brain function.

The ongoing open-label, longitudinal SHORELINE study in patients with MDD (30 mg cohort, 50 mg cohort) found the median time to the first repeat treatment course for patients who responded to the initial 14-day treatment course was 135 days for the completed 30 mg cohort and 249 days for the ongoing 50 mg cohort. The research further supports zuranolone as a potential episodic treatment for people with MDD, according to the study authors.

Some of the key findings from the completed 30 mg cohort of the SHORELINE study, other clinical data and health economics and outcomes research (HEOR), and patient survey, include:

  • In the 30 mg cohort of the SHORELINE study of patients with elevated anxiety and without elevated anxiety, there was a mean reduction in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score from baseline to day 15. Among patients with a HAMD-17 response at day 15 and who continued in the study beyond day 28, scores remained below baseline through day 70 independent of the presence of elevated anxiety at baseline.
  • Among patients with and without elevated anxiety in the 30 mg cohort of the SHORELINE study who responded to the initial 14-day treatment on day 15, approximately 70% received 1 or 2 total treatment courses throughout their time in the study.
  • In patients who accomplished 1 year of follow-up in both cohorts of the SHORELINE study, most had minimal or mild depressive symptoms at the end of the study, as assessed by the Clinical Global Impressions-Severity scale.
  • Zuranolone was generally well-tolerated with a safety profile consistent with prior clinical studies, with the most common adverse events (AEs) associated with zuranolone including headache, somnolence, dizziness, and sedation.
  • Data from a post-hoc analysis of 4 studies in the LANDSCAPE program demonstrated that enhancements in depressive symptoms with zuranolone at day 15 were sustained beyond the end of treatment.
  • A post-hoc analysis of the WATERFALL study in MDD evaluated the statistically significant reduction in depressive symptoms as measured by HAMD-17 on day 15, as well as rapid onset observed on day 3 and day 8 with zuranolone 50 mg versus placebo. This suggested that the differences were clinically meaningful by estimates of minimal important difference, according to the study authors.
  • Results from a cross-sectional survey of US adults with depression found unmet needs in the treatment of MDD. The characteristics most respondents rated as very or extremely important were preventing the recurrence of depression symptoms, fewer AEs, a treatment supported by a body of research on safety and efficacy, being able to discontinue a drug without withdrawal symptoms, fast-acting, and can be repeated if symptoms recur.
  • The health economics data showed that patients with MDD given a prescription for anxiety medication incurred more than double the annual all-cause health care costs than those without an anxiety prescription medication.

“The data presented at Psych Congress highlight the rapid and sustained improvement in depressive symptoms seen with zuranolone in clinical trials and reinforce its potential to be an as-needed treatment in MDD,” said Greg Mattingly, MD, associate clinical professor, Washington University, in a press release. “Depression is a leading contributor to disability worldwide and importantly awareness has grown during the past few years of the global pandemic. We can and must do more to help people living with MDD and those that care about them overcome the challenges of this disease.”

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