Events & Ideas

Our Work

Kratom Safety and Toxicology in the Public Health Context: Research Needs to Better Inform Regulation

Henningfield et al., The growing body of research into kratom benefits, risks, pharmacology, and epidemiology provides a foundation for further research and a basis for federal oversight. FDA regulation of kratom products would support access to products that meet basic standards of purity, product constituent, as well as consistent labeling and warnings. This comprehensive review… Read More

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

Data

Assessment of abuse liability and switching potential of menthol-flavored pod-based electronic nicotine delivery systems among US adults who smoke cigarettes

Menthol-flavored electronic nicotine delivery systems (ENDS) are a focus of public health and regulatory policy considerations. The abuse liability of five menthol-flavored pod-based ENDS was compared to combustible cigarettes, and switching potential of ENDS was also evaluated. Goldenson SI. Shiffman S. Sembower MA. Black RA. Drug Alcohol Depend. 2024 May 1:258:111279. doi: 10.1016/j.drugalcdep.2024.111279. Epub 2024… Read More

Data

Methods Used by US Adults to Stop Smoking Cigarettes, 2020–2022

Foxon F. Niaura R. CDC’s nationally-representative US health survey data (NHIS) asked US adults who stopped smoking completely from 2020–2022 which methods they used to stop. 7.5 million US adults stopped smoking completely from 2020–2022. 54.6% (4.1 million adults) used one or more nicotine products to stop smoking completely from 2020–2022. 42.5% (3.2 million) used… Read More

Data

Rising Uptake of Alternative Nicotine Products (ANPs) by Smoking-Naïve Individuals Is Not Necessarily a Threat to Public Health: The Case of Diversion by Snus in Norway

Selya A and Lund KE. Background: Adults who smoke tobacco can benefit by switching to less-harmful alternative nicotine products (ANPs). However, ANP uptake by smoking-naïve people is a concern. Several publications have reported increasing rates of ANP use by smoking-naïve individuals. However, these concerns seems at odds with historic declines in tobacco smoking in many… Read More

OTC Products

Pinney Associates is honored to have been a part of the teams who worked tirelessly to achieve FDA approval of over-the-counter Opill, the first oral contraceptive to be made available without a prescription in the US (approved July 13, 2023). Popular Science’s 50 greatest innovations of 2023

Prescription Medicines

Nonclinical Studies of Abuse Potential With Dual Orexin Receptor Antagonists: Concordance With Real-World Use

Authors: Moline M, Cheng JY, Henningfield J, Sembower M, Pype S, Buchhalter AR Background: Drugs acting on the central nervous system are subject to a determination of abuse potential prior to regulatory approval in the United States (US). Since the dual orexin antagonists (DORAs) are hypnotics, each approved drug (lemborexant, suvorexant, daridorexant) underwent a comprehensive… Read More