PRECLINICAL DEVELOPMENT OF (2R,6R)-HYDROXYNORKETAMINE FOR HUMAN CLINICAL EVALUATION

Dissociative and psychedelic agents are ushering in a new era of therapy options for a variety of mental health disorders including treatment resistant depression. While promising, the expanded access to these drugs of abuse is worrisome given our ongoing struggles containing the opioid epidemic that began with expanded use of opioid-based pain therapies. The discovery of (2R,6R)-Hydroxynorketamine as an agent that possesses ketamine-like activity in key models of depressive behavior without the dissociative and additive properties has excited the mental health community. Prior to conducting human clinical studies in key patient populations, a series of IND-enabling studies was conducted to set a clinical path for the evaluation of (2R,6R)Hydroxynorketamine in healthy volunteers. This presentation is intended to describe the planning, methods and outcomes of these studiesthat led to the subsequent evaluation of (2R,6R)-Hydroxynorketamine in a phase 1 setting.

References

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