Zuranalone, an investigational once-daily oral therapy, has shown rapid, sustained, and well-tolerated benefit in patients with postpartum depression (PPD) or major depressive disorder (MDD) in a series of trials clinics on a 14-day regimen.
In a new poster highlighting the Phase 2 and 3 clinical program for Sage Therapeutics’ neuroactive steroid and GABAA receptor agonist, presented at the 2022 American Psychiatric Association (APA) Annual Meeting in New Orleans, zuranalone provided significant improvement in outcomes, including the Hamilton Depression Rating Scale ( HDRS) at 17 points, not only at day 15 post-baseline, but after 1 year in the open-label SHORELINE trial extension.
In an interview with HCP Live At APA 2022, poster presenter Anita Clayton, MD, chair of psychiatry and neurobehavioral sciences at the University of Virginia School of Medicine, discussed details of the zuranalone clinical trial program for patients with of PPD or MDD – populations that have for some time been in need of newer therapies.
“Treatment for depression really hasn’t advanced much in the last 20 years,” Clayton said. “A new mechanism of action is quite exciting because there are still a lot of people who don’t respond to the standard treatments of care that we currently have.”
Clayton pointed to the agent’s 15-day improvement in not only patients’ HDRS scores, but also similar benefits in the Montgomery Asberg Depression Rating Scale (MADRS) and overall clinical impression of depression. improvement (CGIC). Throughout this time, zuranalone has been associated with placebo-like side effects.
“It’s not that hard to tolerate something for a 14-day course that you take before you go to bed,” Clayton said.
Clayton detailed the drug‘s unique mechanism of action that may prove to be a more viable option for these patient populations in need.
“Being an analog of allopregnanolone, it binds to GABAA receptors and acts as an agonist – and GABA is the main mechanism in the brain, it affects about 30% of all synapses,” Clayton said. “It also binds to these extra synaptic receptors elsewhere that seem to help with that rapid and sustained response in a very different way to benzodiazepines.”
The poster, “Sustained Improvement in Depressive Symptoms: Results From Zuranolone Clinical Development Program (Major Depressive Disorder/Postpartum Depression)”, was presented at APA 2022.