Nature Medicine publishes promising Phase 2 study on extended-release ketamine for Treatment-Resistant Depression
Douglas Pharmaceuticals, New Zealand's premier pharmaceutical company, has announced promising results from their recent clinical trial, "Randomised Placebo-Controlled Phase 2 Study of Extended-Release Ketamine Tablets (R-107) for Treatment-Resistant Depression" (BEDROC). These findings have been published in the esteemed journal, Nature Medicine.
Dr Peter Surman, the Chief Scientific Officer at Douglas Pharmaceuticals, expressed his satisfaction with the recognition of the study's quality and the significance of its outcomes. He highlighted the potential of R-107 as a transformative medication for individuals suffering from Treatment-Resistant Depression (TRD), noting its suitability for safe, at-home use.
The BEDROC study involved patients with TRD who had not responded to at least two antidepressants during their current depressive episode. The trial demonstrated rapid patient response to R-107 during the daily dose induction phase, with approximately 73% of participants showing improvement within a week. This response rate is comparable to that seen in patients treated with off-label intravenous ketamine, but without the undesired dissociative effects. R-107 appears to be a promising, rapid-acting, and accessible form of ketamine.
Dr Surman also acknowledged the contributions of Douglas' Product Development Team, the trial investigators, and Professor Paul Glue from the University of Otago. Professor Glue, who has over two decades of experience in pharmaceutical research with a focus on mood disorders and the use of ketamine for TRD, serves as the Chair of the Clinical Advisory Board for R-107 and the Trial Steering Committee for BEDROC.
Professor Glue commented that the BEDROC study showcased the possibility of achieving significant antidepressant effects from ketamine without notable dissociation. The study exhibited a clear dose-response over three months, meeting the primary efficacy endpoint at Day 92, particularly in the 180 mg dose arm, which separated significantly from placebo. This success provides confidence to move forward with pivotal registrational clinical studies.
The BEDROC study indicated that R-107 was well tolerated, a finding supported by the follow-up six-month open-label study (BEDROC-1). Most adverse events were mild, and no safety concerns were identified. Unlike rapid-release ketamine forms, such as intranasal esketamine, which require clinical administration and observation due to significant dissociation and sedation effects, R-107's adverse effects were mild, allowing for at-home administration without safety issues.
After completing up to nine months of treatment in the BEDROC and BEDROC-1 studies, a significant number of patients (106) were enrolled in a compassionate use program, with the average treatment duration currently at two years. Most patients in this program continue to receive 180 mg of R-107 twice weekly.
About Treatment Resistant Depression: Major Depressive Disorder (MDD) affects approximately 60 million people in the United States and Europe, with about one-third classified as treatment-resistant, having failed two or more antidepressants during their current depressive episode.
About R-107:
R-107 is an extended-release oral formulation of ketamine designed for TRD patients. The medication releases ketamine slowly, maintaining low systemic concentrations to minimize dissociative side effects. An Investigational New Drug (IND) application is active with the US FDA for all required studies to support regulatory submission. Douglas Pharmaceuticals is open to collaborating with potential partners and investors to advance Phase 3 development and commercialization of R-107.
About Douglas Pharmaceuticals:
Headquartered in Auckland, New Zealand, Douglas Pharmaceuticals is a privately held company specializing in the development and manufacture of generic and repurposed medicines available worldwide. Their mission is to improve lives through innovative, competitive, and high-quality healthcare solutions, focusing on areas such as oncology, dermatology, the central nervous system, and immunology. The company prioritizes products with strong intellectual property and technical complexity to address unmet medical needs.
About Nature Medicine:
Nature Medicine is a leading peer-reviewed scientific journal that publishes research across all medical disciplines. The journal holds a 2022 two-year impact factor of 82.9.
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