Psychedelics and Psychiatry: A Roadmap to Evaluate the Safety, Abuse Potential, and Efficacy of Psychedelics in Early Phase Drug Development
With Dr Sharon Cheetham (Sygnature Discovery) and Dr Beatrice Setnik (Altasciences)
There are a number of psychiatric disorders with high unmet clinical need where psychedelics are increasingly being looked to as a potential therapy. Psychedelics have established human abuse potential, and many are Schedule I Controlled Drugs (CDs), i.e. not approved for medical use. Therefore the production, distribution and supply is tightly controlled and regulated. Supporting regulatory approvals for medical use requires safety and efficacy evaluations. For psychedelics in development, regulatory approval will require a shift from Schedule I CD, to a CD schedule for medical use. In this webinar we will discuss the clinical and non-clinical studies required for evaluation of abuse risks of psychedelic drugs. Data for the various types of psychedelics in pre-clinical drug-discrimination, intravenous self-administration and physical dependence models will be presented. We will review the regulatory guidance and offer advice on how these studies can be designed to meet the expectations of FDA, and other regulatory agencies. We will also review safety studies and early examinations of efficacy that can help guide drug development decisions for later phase patient trials.