Long Term Safety and Efficacy of Oral Extended-Release Ketamine: Results from the Bedroc-1 Study

There is growing evidence and interest in the use of ketamine for major depressive disorder (MDD). R-107, an oral extended-release ketamine tablet, effectively alleviated symptoms within a treatment-resistant depression (TRD) population in an earlier randomized control trial (BEDROC study). This open label extension study (BEDROC-1) explores the 6-month safety and efficacy of R-107 with 153 subjects from the previous BEDROC study. The most common adverse events in the BEDROC-1 study included dizziness (22.2%), headache (22.2%), depression (16.3%), anxiety (15.7%) and depressive symptoms (13.1%) and was consistent with the short term BEDROC study. The relapse-free rate of the subjects who entered the study in remission was 93%. Most doses were taken at home, with an average 96.3% drug compliance rate and no obvious evidence of abuse or diversion. R-107 is an attractive treatment candidate in TRD patients with a robust safety profile in long-term use and no evidence of misuse.