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Prescription Medicines

Comment on NDA for Lykos’ MDMA from Dr. Marion Coe

Marion Coe, Director, Clinical Development and Postmarketing Surveillance at Pinney Associates I support approval of midomafetamine (MDMA) capsules for the treatment of posttraumatic stress disorder (PTSD). This medication assisted therapy holds significant potential for public health benefit by providing an effective treatment for PTSD, a condition affecting millions of people. It is likely to contribute… Read More

Prescription Medicines

Comment on NDA for Lykos’ MDMA from Dr. Jack Henningfield

Jack Henningfield, Vice President, Research Health Policy and Abuse Liability, Pinney Associates. I support the approval of MDMA for the treatment of post-traumatic stress disorder (PTSD). Phase 2 and 3 studies have demonstrated efficacy and, equally importantly, the studies have shown that it can be used safely under various conditions and approaches to therapeutic use… Read More

Prescription Medicines

Comment to Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids (Docket No. CDC-2022-0024)

Schnoll S, Beck R, Henningfield J, Ashworth J. The 2022 revision is a positive step forward in addressing the challenges that worsened the disparities in access to pain medicines that resulted from the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain – United States. READ OUR COMMENT

Dietary Ingredients & Supplements

Comment to FDA: World Health Organization ECDD Report Addressing the Review Status of Kratom and Its Alkaloids (Docket No. FDA-2022-N-0105)

Henningfield JE, Huestis MA, Grundmann O, Swogger MT, Prozialeck WC, Garcia-Romeu A, McCurdy CR. This is a collaborative comment of concerned scientists regarding the WHO ECDD report addressing the review status of kratom and its alkaloids. READ OUR COMMENT

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

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