The psychedelics and MDMA are leading a revolution in the treatment of many psychiatric disorders. These drugs act by modifying the function of serotonin neuronal pathways in the brain. DevelRx scientists are experts in the pharmacology of serotonergic drugs. Our research on these drugs dates back more than 30 years with published articles, reviews, books and presentations at international scientific congresses.
DevelRx are working with academic researchers and regulatory agencies to define the framework to exploit the tremendous potential that the psychedelics and MDMA offer to patients. We are leaders in devising research strategies to discover the next generation of drugs in this field and to evaluate the risks for human abuse that will accompany them.
Cannabinoids are another group of botanical compounds that have medical use in psychiatric and neurological disorders. Sharon Smith and David Heal supported the development of cannabidiol (Epidiolex in the US; Epidyolex in Europe) for the treatment of rare and severe forms of childhood epilepsy.
DevelRx have also provided toxicology guidance and safety pharmacology evaluations to various manufacturers of cannabidiol dietary supplements for the submission of dossiers to the FSA and EFSA for cannabidiol-based novel foods.
Publications illustrating our experience in this field and how we can assist with the challenges faced by developers of novel therapies from psychedelics and cannabinoids are shown below.
Edited Books and Special Issues
Heal DJ, Smith SL Henningfield J Frenguelli B, Nutt DJ. Special Issue of Neuropharmacology - “Psychedelics”, 2018.
Heal DJ, Gosden J, Smith SL, Atterwill CK. Experimental strategies to discover and develop the next generation of psychedelics and entactogens as medicines. Neuropharmacol, 2023; 225: 109375. doi.org/10.1016/j.neuropharm.2022.109375.
Henningfield JE, Ashworth J, Heal DJ, Smith SL. Psychedelic drug abuse potential assessment for new drug applications and controlled substance scheduling: A United States perspective. J Psychopharm, 2023; 37(1): 33-44. doi: 10.1177/02698811221140004.
Henningfield JE, Coe MA, Griffiths RR, Belouin SJ, Berger A, Coker AR, Comer SD, Heal DJ, Hendricks PS, Nichols CD, Sapienza F, Vocci FJ, Zia FZ. Psychedelic drug abuse potential assessment research for new drug applications and Controlled Substances Act scheduling. Neuropharmacol, 2022; 218: 109220. doi.org/10.1016/j.neuropharm.2022.109220.
Gray RA, Heal DJ, Maguire DR, Gerak LR, Javors MA, Smith S, France CP. Preclinical assessment of the abuse potential of purified botanical cannabidiol: self-administration, drug discrimination, and physical dependence. J Pharmacol Exp Ther, 2022 Jul; 382(1): 54-65. doi: 10.1124/jpet.121.000988. Epub 2022 Apr 30.
Heal DJ, Henningfield J, Frenguelli BG, Nutt DJ, Smith SL. Psychedelics - Re-opening the doors of perception. Neuropharmacol, 2018; 142: 1-6.
Gosden J, Smith S, Atterwill C, Heal D. Essential experimental screening to evaluate the safety of novel psychedelics. T161. College on Problems of Drug Dependence Meeting, Denver, Colorado, USA, 17th-21st June 2023.
Gray RA, Heal DJ, Maguire DR, Gerak LR, Javors MA, Smith SL, France CP. Investigation of the reinforcing and discriminative properties of highly purified botanical cannabidiol in rats and monkeys. M233. American College of Neuropsychopharmacology Meeting, Orlando, Florida, USA, 8th-11th December 2019.
Heal DJ, Holland S, Gosden J, Gray RA, Smith SL. An investigation of the discriminative stimulus and reinforcing effects of cannabidiol in rats. 373.13. Society for Neuroscience Meeting, San Diego, California, USA, 3rd-7th November 2018.
Safety Pharmacology Society Virtual Meeting, 4th-8th October 2021.
Talk entitled "Psychedelics and CNS Drugs with Novel Mechanisms. Non-clinical Abuse Evaluations to Meet the Challenge". Part of the Continuing Education (CE) course "CNS Biomarkers of Mood Disorders and Drug Abuse: Where are We?" associated with the SPS Virtual Meeting, 11th October 2021.
DevelRx - Altasciences Joint Podcast, 21st September 2021.
Podcast entitled "The Next Trip - Developing the Second Generation of Psychedelics and their Analogs for Targeted Medical Use". In this podcast, experts from DevelRx and Altasciences examined the preclinical, clinical and regulatory challenges facing the development of more efficacious and safer psychedelic drugs.
College on Problems of Drug Dependence Workshop at Virtual Meeting, 21st-24th June, 2021.
Talk entitled: "Refinements and Innovations in Non-clinical Abuse Evaluations" in Workshop "Meeting the Challenge of the Psychedelics and CNS Drugs with Novel Mechanisms - Building on the Foundation of the FDA 2017 Guidance on the Assessment of Abuse Potential". 23rd June 2021.
Psychedelic Therapeutics and Drug Development Conference (Virtual Meeting), 4th-6th May 2021.
Talk entitled: “How non-clinical research can inform the clinical development and prescribing of psychedelic drugs.”
College on Problems of Drug Dependence Workshop at Annual Meeting, San Diego, California, USA, 9th-14th June 2018.
Talk entitled: “An evaluation of the discriminative and reinforcing properties of cannabidiol in rats." In Workshop "Therapeutic Applications and Abuse Liability Assessment of Cannabidiol".
Pinney Associates – RenaSci Supported International Webex, 2018.
Developing Psychedelics into Medicine: Potential and Pitfalls. Talk entitled: “Developing psychedelic drugs for medical use - dealing with the regulatory challenge of non-clinical abuse and dependence assessments.”
AddRess - Center for Addiction Research & Science, 2018.
Talk entitled: “Developing psychedelic drugs for medical use – regulatory challenges.”
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