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Withdrawal Are Important in the CSA 8-Factor Analysis to Inform Drug Scheduling Recommendations

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Withdrawal Are Important in the CSA 8-Factor Analysis to Inform Drug Scheduling Recommendations Jack E. Henningfield, Ph.D. Vice President, Research, Health Policy and Abuse Liability Pinney Associates And Professor, Adjunct, Behavioral Biology Department of Psychiatry and Behavioral Sciences The Johns Hopkins University School of Medicine Presented at ASAM, April 9, 2017, from 8:30-10:00 am at the Grand Salon A, In the Symposium: Evaluating Drug Dependence: Regulatory, Methodological and Clinical Challenges. New Orleans Hilton Riverside 1 PinneyAssociates.com Through PinneyAssociates, I provide consulting services on the development and regulation of pharmaceutical products and electronic nicotine delivery systems for which development goals may include reduced abuse potential. This includes abuse potential assessment and abuse-deterrent drug formulation evaluation to inform scheduling and abuse-deterrent labeling recommendations. 2 PinneyAssociates.com Parallels with one of the 20th century’s top 10 public health advances: Cars made with better materials and designs, and safeguards to protect passengers, better education, and with regulatory standards and oversights that incentivizes advances by industry 3 PinneyAssociates.com 1. Developing medicines with lower risks of abuse and physical dependence – a shared goal of FDA, public health, and pharmaceutical companies 2. Goals and challenges for new medications development 3. Definitions and why they matter 4. Clinical trials: At the intersection of research and clinical practice: A critical but challenging opportunity to characterize the abuse and physical dependence potential of new medicines 5. The Controlled Substances Act (CSA) 8 Factors to guide drug scheduling recommendations by FDA, NIDA and DEA 4 PinneyAssociates.com 1. FDA incentivized pharma with the potential for less restrictive scheduling and abuse deterrent labeling for opioids – but it needs science to get it right 2. The roadmap offered by the 2017 final Guidance for Assessment of Abuse Potential of Drugs provides a path and a basis for decision making for scheduling 3. The 2015 Opioid Abuse Deterrent Guidance recommends research strategies to achieve potential abuse deterrent claims 4. Clinicians and researchers can have input and help keep FDA and pharma on the right path 5 PinneyAssociates.com 1. Better medicines may be important in reducing prescription abuse and overdose but this may drive some to illicit drugs. We also need: 2. Better education of the public and prescribers 3. Better balance of prevention and treatment efforts to reduce demand along with supply reduction efforts 4. Nationwide implementation of strategies advocated by ASAM & NIDA 5. As Dr. Koop said in his 90th birthday address: 1. Politics should serve public health and not the other way around 2. We need to make it as easy to get treatment as it is to get addicting drugs 6 PinneyAssociates.com 1. Physical dependence and withdrawal are important in the CSA 8-Factor Analysis to inform drug scheduling recommendations 2. Labeling must describe the nature and course of potential withdrawal symptoms and how they can be minimized and treated 3. Phase 3 trials provide the closest approximation to real world clinical use, with the chronic exposure that would be expected to produce dependence and lead to abuse and diversion – if those are risks of the drug 4. NDAs for CNS drugs must include an abuse potential assessment, including Phase 3 data, to inform the FDA’s scheduling recommendation to DEA 7 PinneyAssociates.com Serve Patients & Providers Deter Abuse & Overdose – primarily in nonpatients Patients want effective, fast acting, easy and flexible to use Those same features can be attractive to non-patients seeking mood alteration medicines (e.g., can crush and put in apple sauce) Formulations & effects intended to discourage abuse in non patients may Minimize risk of adverse effects & introduce new potential risks quality of life impairing effects It can take many years and great expense to develop and get approved a product that Support compliant use while may discourage abuse but offers little or no minimizing iatrogenic addiction benefit that patients or insurance (or, e.g., risk the VA) will pay for 8 PinneyAssociates.com “Addiction is a primary, chronic disease of brain reward, motivation, memory and related circuitry. Dysfunction in these circuits leads to characteristic biological, psychological, social and spiritual manifestations. This is reflected in an individual pathologically pursuing reward and/or relief by substance use and other behaviors. Addiction is characterized by inability to consistently abstain, impairment in behavioral control, craving, diminished recognition of significant problems with one’s behaviors and interpersonal relationships, and a dysfunctional emotional response. Like other chronic diseases, addiction often involves cycles of relapse and remission. Without treatment or engagement in recovery activities, addiction is progressive and can result in disability or premature death.” See complete ASAM definition for more detail 9 PinneyAssociates.com ! Patient: “Doctor, will this drug make me addicted? The label says it may cause dependence and withdrawal” ! Doctor: “The risk of dependence when used according to the labeling is low but your body will develop tolerance and may become physically dependent so we will need to taper you off it when you no longer need it to minimize your withdrawal” ! Patient: “Huh? You mean my body is addicted but I’m not? That doesn’t make sense. Are you a medical marijuana user?” 10 PinneyAssociates.com ! Drug abuse is defined as the intentional, non-therapeutic use of a drug product or substance, even once, to achieve a desired psychological or physiological effect. Therefore, abuse potential refers to the likelihood that abuse will occur with a particular drug product or substance with CNS activity. Desired psychological effects can include euphoria, hallucinations and other perceptual distortions, alterations in cognition, and changes in mood. ! Dependence refers to physical or psychological dependence. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. ! Psychological (or psychic) dependence refers to a state in which individuals have impaired control over drug use based on the rewarding properties of the drug (ability to produce positive sensations that increase the likelihood of drug use) or the psychological distress produced in the absence of the drug. Continued -- 11 PinneyAssociates.com ! Tolerance is a state that develops as a result of physiological adaptation characterized by a reduced response to a specific dose of drug after repeated administration of the drug (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). ! The presence of physical dependence or tolerance does not determine whether a drug has abuse potential. Many medications that are not associated with abuse, such as antidepressants, betablockers, and centrally acting antihypertensive drugs, can produce physical dependence and/or tolerance after chronic use. ! However, if a drug has rewarding properties, the ability of that drug to induce physical dependence or tolerance may influence its overall abuse potential. 12 PinneyAssociates.com ! Assessment of abuse potential and potential to produce physical dependence and withdrawal were relatively simple largely based on small scale laboratory studies (e.g. animal drug self-administration & withdrawal) and human lab studies of abuse potential & withdrawal ! Most substances in development fit reasonably neatly into one of few classes: namely opioids, stimulants and sedatives ! Phase 3 clinical trial data were not a major factor in scheduling decisions 13 PinneyAssociates.com ! They address new novel acting substances and products designed to reduce abuse/dependence can be more challenging to characterize in part due to weaker or novel effects ! They guide study planning from bench & clinical trials to post- marketing for the overall abuse potential assessment portfolio with a menu of suggestions to be considered (and ideally discussed with FDA) ! They provide a path toward potential less restrictive scheduling and other labeling claims to incentivize pharmaceutical development 14 PinneyAssociates.com ! No single test or characteristic alone is predictive [for scheduling] ! Composite of multiple sources of data ! Evaluation of: " Chemistry " Pharmacology (animal and human) " Pharmacokinetics & pharmacodynamics " Adverse events reported in clinical trials ! Compare to a pharmacologically similar substance (From FDA, Mike Klein, October 26, 2007 – See 2017 Guidance for “road map”) 15 PinneyAssociates.com ! Reliance on Phase 3 trial data was increasingly encouraged by FDA since about 2002 ( at CPDD/NIDA/ FDA conference – Special DAD Issue 2003) ! Phase 3 trials primarily designed for efficacy and safety, not abuse and physical dependence potential ! Often lack balanced dose manipulations and appropriate comparator drugs that are important in abuse/withdrawal determinations ! Many drugs are intended to make patients feel better and feel good – but not “high” or “inappropriately euphoric” may provide confusing signals ! Study site staff training and experience in such assessments varies 16 PinneyAssociates.com ! Yes! I can finally – " Sleep " Function " Deal with stress " Hug my kids " Dance ! How to distinguish from inappropriate euphoria? ! Similarly,
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