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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

Dietary Ingredients & Supplements

Kratom policy: The challenge of balancing therapeutic potential with public safety

Prozialeck WC, Avery BA, Boyer EW, Grundmann O, Henningfield JE, Kruegel AC, McMahon LR, McCurdy CR, Swogger MT, Veltri CA, Singh D. The International Journal on Drug Policy 70:70–77, 2019 View publication

Dietary Ingredients & Supplements

A Reply to CDC Report on Unintentional Drug Overdose Deaths with Kratom Detected (2019); appropriate regulation of kratom and improved postmortem testing protocols are needed immediately

Henningfield J.E., Grundmann, O., Babin, J., Laredo, G., and Cone, E. View PDF

Dietary Ingredients & Supplements

Analysis of FDA’s October 17, 2017 “Basis for the recommendations to control mitragynine and 7-hydroxymitragynine in Schedule I of the Controlled Substances Act”

Henningfield JE, Babin J, Boyer EW, Brown P, Garcia-Romeu A, Griffiths RR, Grundmann O, Hemby SE, McCurdy CR, Raffa RB, Swogger MT, Walsh Z November 28, 2018 View PDF

Dietary Ingredients & Supplements

Kratom Science Letter to US Congressional Leadership on Kratom Science and Policy

Henningfield JE, Swogger MT, Walsh Z, Kruegel AC, Grundmann O, Garcia-Romeu A, Raffa RB, Griffiths RR, Brown P June 12, 2018 Dear Leader McConnell, Leader Schumer, Speaker Ryan, and Leader Pelosi: We write today to address the U.S. Food and Drug Administration’s (FDA) recommendation to the Drug Enforcement Administration (DEA) to schedule the kratom plant… 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

OTC Products

Rx to OTC Switch (Part 2 of 2): Planning for Commercial Success

Christine Sweeney, PhD, MPH, Director, Issues Management, Pinney Associates George Quesnelle, Senior Strategic Advisor, OTC Commercialization and Optimization, Pinney Associates Presented February 22, 2018 Visit Webinar Website