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Abuse Potential Related Science and Regulatory Perspectives for Psychedelic Drug Product Development

Jack Henningfield, PhD, Vice President, Research, Health Policy, and Abuse Liability, Pinney Associates Presented as part of the NIH Psilocybin Speaker Series, April 22-June 10, 2021 VISIT THE SPEAKER SERIES WEBSITE

Prescription Medicines

Design and Operational Challenges in Psychedelic Clinical Trials

Marion Coe, PhD, Director, Clinical Development and Postmarketing Surveillance, Pinney Associates Presented as part of the session Hot Topics in Psychedelic Drug Development: From Successful Clinical Trials to Maximizing Benefits in the Post-approval World, May 5, 2021 VISIT THE CONFERENCE WEBSITE

Prescription Medicines

Targeting Differences: Strategies to Demonstrate the Benefits of Novel CNS-active Analgesics

Moderator Jack Henningfield, PhD, Vice President, Research, Health Policy, and Abuse Liability, Pinney Associates Panelists David Heal, PhD, DSc, FRSC, FBPhS, Executive Director, DevelRx Ltd. Reginald Fant, PhD, Director, Clinical Pharmacology and Abuse Potential Assessment Judy Ashworth, MD, Vice President, Rx Strategic Services and Chief Medical Officer, Pinney Associates Presented at the 14th Annual Pain… Read More

Prescription Medicines

Comment to the FDA: Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction (Docket No. FDA-2019-N-2514)

Judy Ashworth, MD, Vice President, Rx Strategic Services and Chief Medical Officer, Pinney Associates These comments are submitted in response to the Federal Register notice Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction, Docket FDA-2019-N-2514. This is a written version of comments made orally at the September… Read More

Prescription Medicines

The nexus of opioids, pain, and addiction: Challenges and solutions

Henningfield JE, Ashworth J, Gerlach KK, Simone B, Schnoll SH Preventive Medicine, 128:10582, 2019. Special Issue on Opioids Addiction and Pain, 2019. Pain and addiction are complex disorders with many commonalities. Beneficial outcomes for both disorders can be achieved through similar principles such as individualized medication selection and dosing, comprehensive multi-modal therapies, and judicious modification… Read More

Prescription Medicines

The abuse potential of medical psilocybin according to the 8 factors of the Controlled Substances Act

Johnson M, Griffiths R, Hendricks P, Henningfield JE Neuropharmacology, 142:143-166, 2018. This review assesses the abuse potential of medically administered psilocybin, following the structure of the 8 factors of the US Controlled Substances Act (CSA). Research suggests the potential safety and efficacy of psilocybin in treating cancer-related psychiatric distress and substance use disorders, setting the… Read More

Prescription Medicines

Psychedelics: Where we are now, why we got here, what we must do

Belouin S, Henningfield JE Neuropharmacology, 142:7-19, 2018. The purpose of this commentary is to provide an introduction to this special issue of Neuropharmacology with a historical perspective of psychedelic drug research, their use in psychiatric disorders, research-restricting regulatory controls, and their recent emergence as potential breakthrough therapies for several brain-related disorders. It begins with the… Read More