Following decades of stagnation, the field of psychedelic research is being revitalized by the investigation of their potential benefit for mainstream psychiatric applications. This includes treatments for opioid addiction, depression, PTSD, and Alzheimer’s disease. As encouraging data increase and the policy environment evolves, there is a growing shift in attitude from vilification to compassion. These drugs are increasingly being recognized for their potential to optimize mental health, while various molecular modifications are being explored in an attempt to deliver similar benefits while attenuating risks. The potential promise of the second generation of psychedelics is fewer side effects, greater safety, and a lower likelihood of abuse.
MAPPING THE rOAD TO rEGULATORY aPPROVAL
Leading industry experts from Altasciences and DevelRX recently got together to discuss the preclinical, clinical, and regulatory requirements of bringing second generation psychedelics to market. In this podcast episode, they considered how the safety, efficacy, and abuse potential of these new drugs can be evaluated in relation to that of already existing psychedelics like psilocybin or LSD. In addition, several possible strategies for differentiating the pharmacological profile of second generation psychedelics from that of their predecessors are examined.
The first in a series of podcasts is titled The Next Trip – Developing the Second Generation of Psychedelics and their Analogs for Targeted Medical Use. It provides an in-depth exploration of some of the intricacies involved in conducting leading edge research in the field. Indicators of hallucinogenic properties are discussed within the context of preclinical trials, while the appropriate means of assessing safety and reducing toxicity are explored at the clinical stage.
Navigating the regulatory requirements for CNS active drugs requires highly specialized skills and knowledge, and the panelists from Altasciences and DeveIRX pay particular attention to how these relate to second generation psychedelics. Dr. Beatrice Setnik, Altasciences’ Chief Scientific Officer says, “You need to have well-controlled, well-designed trials to support the regulatory package and enable appropriate labelling that enables a sponsor to differentiate their products from others in the marketplace.”
bringing your project to life
An integrated, streamlined drug development process incorporating preclinical through clinical trials, and beyond, is paramount to reaching your milestones as quickly and efficiently as possible. With extensive expertise in the field of CNS active compounds, Altasciences is ideally suited to partner with you on your second generation psychedelics trials.