Pinney Associates, Inc.

Psychedelic substances have great promise and substantial and critical uncertainties as potential new medicines for psychiatric and other disorders. Jack E. Henningfield will discuss how to approach regulatory pathways with FDA and DEA to support timely approval, appropriate scheduling under the Controlled Substances Act, and the importance of anticipating abuse potential assessment needs for the New Drug Application. Schedule 1 drugs such as psychedelics submitted to FDA for approval present unique challenges for collection and interpretation of adverse events (AEs). #AmericanAcademyofAddictionPsychiatry #AddictionPsychiatry #AnnualMeeting #AAAP24 #FDA #regulatory #AdverseEvents #ClinicalTrials #Psychedelics #PsychoactiveDrugs #drugscheduling

Check out this new paper by our scientists and data team.

We are pleased to share the news of two promotions. Arielle Selya, PhD has been promoted to Senior Scientist. In the four years since joining Pinney Associates, Arielle has supported clients seeking to define and address complex issues around consumer behavior and use of reduced-risk consumer products. Floe Foxon has been promoted to Scientist and Data Analyst. Floe joined Pinney Associates as a data analyst in 2020, applying his expertise in data management and modeling.? #data #science #womeninscience #consumerhealth #statisticalanalysis

Ryan Lanier, PhD is at the Pain Therapeutics Summit and available for discussions about how we can support #FDA #regulatory strategy, #clinical #drugdevelopment, and abuse potential assessment, for #CNS-active drugs including new #analgesics. https://lnkd.in/ez_Yt6jW

Inspired by the work of well-respected and impartial authors related to the gateway hypothesis controversy around e-cigarettes and cigarette smoking, Arielle Selya and Joe Gitchell highlight this opportunity for ‘adversaries’ to draw motivation from peers in other fields taking the risks and putting in the efforts to find common ground. #openaccess #ecigarettes #cigarettesmoking #publichealth #gatewayhypothesis https://lnkd.in/egJ5TZv4 https://lnkd.in/egJ5TZv4

This new peer-reviewed article confirms the findings of a previous article and updates the original paper with new data and expanded analyses. The new article finds that cigarette smoking prevalence in the e-cigarette era was significantly lower than expected, in ways correlated with increased e-cigarette use. The present paper was self-funded by Pinney Associates, and the previously published version was funded by Juul. Authors include Floe Foxon, Arielle Selya, Joe Gitchell, Saul Shiffman #data #science #publichealth #smokingcessation #statisticalanalysis #ecigarettes #epidemiology #populationtrends #openaccess? https://lnkd.in/eJx8geb9

Congratulations to Arielle Selya on her paper describing the variety of different definitions used to track and study youth e-cigarette use, and how such distinctions subsequently may relate to individual and public health. They discuss how some definitions more often capture transient experimentation, while others better capture problematic use patterns that could pose health risks. #openaccess #ecigarettes #publichealth #nicotine #surveillance #data #behavioralhealth #adolescents The authors received no financial support for the research, authorship, and/or publication of this article. https://lnkd.in/ePYcnd5K

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 provides the current science base on kratom. Co-authors: Jack E. Henningfield, Oliver Grundmann, Marilyn Huestis and Kirsten E. Smith #science #publichealth #FDA #kratom #openaccess #mitragynine #abusepotential #toxicology #epidemiology #surveillance #neuropharmacology? https://lnkd.in/giwJvmVw

Ryan Lanier will share insights on the importance of collecting and assessing abuse-related adverse events (ARAEs) from clinical trials of #psychedelics and novel #psychoactive drugs as part of an overall abuse potential assessment. As recommended by #FDA in its 2017 abuse potential guidance, and further described in its 2023 guidance on conducting clinical investigations of psychedelic drugs, clinical trial #protocols should include a prospective and systematic plan for collecting, assessing, and reporting all ARAEs to better inform drug scheduling and labeling decisions. #CPDD24 #AdverseEvents #ClinicalTrials #PsychoactiveDrugs #drugscheduling?

Caitlyn Durgin will present this poster on the development of new #analgesics at CPDD. Clinically meaningful efficacy and safety profiles could help meet the critical unmet medical and public health need for new therapies to treat #pain and improve emotional and physical functioning, and quality of life. Clinical development plans responsive to FDA guidance anticipate the need for rigorous assessment of abuse-related adverse events for drugs that have #CNS activity, novel endpoint evaluation, and potential inclusion of combination therapy approaches.? #CPDD24 #AdverseEvents #ClinicalTrials #clinicaldevelopment #FDA