NAVIPPRO Signal e-newsletter: NAVIPPRO collects product-specific data on stimulant abuse


	October 5, 2009 \| ISSUE 13

	Welcome to the NAVIPPRO Signal. We are pleased to announce that we have added real–time, product–specific data on stimulant use by both adults and adolescents to the surveillance component of the National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO). These data, systematically collected from patients entering treatment for substance abuse, represent the first such data of their kind, and can assist makers of stimulant medications in establishing such factors as the relative rate of abuse of a particular formulation versus a comparator. Below is an article on the addition of stimulant data to NAVIPPRO surveillance, as well as details on recent enhancements to InsideADHD.org, an educational program designed to reduce the risk of diversion, misuse, or abuse of stimulant medications indicated for Attention Deficit/Hyperactivity Disorder (ADHD). In addition, for those following developments relevant to opioid risk management, we provide pointers to information about the recent FDA Advisory Committee meetings on new drug applications (NDAs) for two opioid medications: Exalgo^™ (hydromorphone HCl) Extended–Release Tablets and OxyContin^™ (oxycodone hydrochloride controlled-release) Reformulated Tablets. We hope you find this issue of NAVIPPRO Signal useful. If you have any questions about NAVIPPRO or our research, please feel free to contact us. Sincerely, The NAVIPPRO team Back to top NAVIPPRO collects product–specific data on stimulant abuse by adults and adolescents A new study published in the journal Pediatrics has revealed a sharp increase in the number of calls to poison control centers regarding teen abuse of prescription medication indicated for Attention Deficit/Hyperactivity Disorder (ADHD). In an analysis of data collected by the American Association of Poison Control Center’s National Poison Data System from 1998-2005, researchers found a 76% increase in the number of calls related to the abuse of ADHD medications by adolescents.¹ NAVIPPRO recently added real-time, product–specific surveillance data on stimulant abuse by adult and adolescent patients in treatment for substance abuse, to help in understanding the risk/benefit balance of stimulants, the class of medications most commonly prescribed for ADHD. These data are systematically collected through the Addiction Severity Index – Multimedia Version (ASI-MV^©) Connect network of substance abuse treatment centers. These centers, which now number over 500, use the ASI–MV Connect program routinely as part of the clinical workflow, to conduct patient assessments. The ASI–MV Connect program collects the stimulant data through the assessment interview. The program′s technology was designed specifically to allow Inflexxion to rapidly add, subtract, or modify the questions being asked of patients. In the September 3, 2009 update to the program, Inflexxion added questions to collect data on the following branded stimulant medications: Daytrana^™ Concerta^® Metadate CD^® Metadate ER^® Methylin^® Methylin ER^® Ritalin^® Ritalin LA^® Ritalin SR^® Focalin^® Focalin XR^® Adderall^® Adderall XR^® Dexedrine^® Dexedrine Spansules^® Dextrostat^® Vyvanse^™ Strattera^® Desoxyn^® The most recent version of the ASI–MV Connect program includes access to the Comprehensive Health Assessment for Teens (CHAT^™), an assessment instrument designed specifically for patients ages 13–18. CHAT, launched in June 2009, already collects data on the above stimulants. “The recent analysis of data from poison control centers indicates an alarming rise in the abuse of ADHD medications among adolescents, and this warrants further investigation,” says Theresa Cassidy, M.P.H., Director of Epidemiology at Inflexxion. “For drug sponsors who are developing strategies for mitigating the risks of stimulant medications, there are a number of critical questions: Which specific medications are adolescents abusing? Are particular formulations more attractive to abusers? And, if we′re seeing more young teens abusing these drugs, what are the best methods for ensuring that ADHD medication is used safely and not ‘shared’ with others?” The stimulant data collected through the current adult ASI–MV Connect and the adolescent CHAT assessment interviews include information on the specific product being abused, where the patient obtained the product, and the route of administration used. The program also obtains geographic data for each patient, which, due to the real–time nature of the data, allows for the analysis of spatial and temporal patterns of abuse throughout the country. “This information can be used to develop targeted prevention and intervention programs, and to gauge the impact of these programs over time,” notes Cassidy. As part of NAVIPPRO′s comprehensive approach to risk management, Inflexxion develops and deploys prevention and intervention programs. In September, we made several key enhancements to InsideADHD.org, a program targeted to the parents of children with ADHD and adults with ADHD. The enhancements included publishing a new Parent Toolkit with practical tools for minimizing the risks of ADHD medications, such as age–appropriate medication contracts that parents can use with children; a medication log for tracking the use of medications; and template letters for communicating with doctors, teachers, and school nurses about a child′s condition and medication requirements. If you have specific questions about the addition of stimulants to NAVIPPRO surveillance, or would like to discuss how we can assist you in developing your risk management strategies, please feel free to contact us. Back to top FDA holds Advisory Committee meetings on Exalgo^™ and OxyContin^™ NDAs On September 23 & 24, 2009, the FDA held a joint meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The meeting was to discuss two new drug applications (NDAs) for opioid medications: Neuromed’s Exalgo^™ (hydromorphone HCl) Extended–Release Tablets and Purdue′s OxyContin^™(oxycodone hydrochloride controlled–release) Reformulated Tablets. Following are details on the meetings: NDA – Exalgo^™ (Neuromed) - Sept. 23: The committees discussed NDA 21-217, Exalgo^™ (hydromorphone HCl) Extended–Release Tablets, a modified-release hydromorphone drug product indicated for the treatment of moderate–to–severe pain in opioid tolerant patients. Specifically, the committees discussed: Where Exalgo^™ lies in the spectrum of risk for abuse, including abuse-related overdose and death, compared to other opioid products Based on the committees’ assessment of the risk associated with abuse of Exalgo^™, which of the following options would be appropriate for risk management: a. A program similar to Onsolis^™, including registration for physicians and patients b. An opioid class-like program including physician education and registration, but no patient registry and, in the short term, an interim Risk Evaluation and Mitigation Strategy (REMS) pending the larger opioid class program as was done with EMBEDA^™ c. A unique program NDA – OxyContin^™ (Purdue Pharma) Sept. 24: The committees discussed NDA 22–272, OxyContin^™ (oxycodone hydrochloride controlled–release) Reformulated Tablets, Purdue Pharma L.P., and its safety for the proposed indication of management of moderate to severe pain when a continuous, around–the–clock analgesic is needed for an extended period of time. This formulation was previously reviewed and discussed by these committees on May 5, 2008, and is being considered again in light of new data. Specifically, the committees discussed: Whether the studies performed by the sponsor adequately characterize the physical attributes of the reformulated OxyContin^™ product Whether the change in formulation affects the overall safety profile of OxyContin^™ Whether this application for a reformulated OxyContin^™ should be approved The rationale for the decision The panel recommended approval of the application to replace the existing formulation with the new formulation of OxyContin^™ with a 14–4 vote, with one member abstaining. Back to top References ¹Setlik, J., Bond, G.R., & Ho, M. (2009). Adolescent prescription ADHD medication abuse is rising along with prescriptions for these medications. Pediatrics 124(3): 875-880. Back to top About NAVIPPRO The National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO) is a public health-oriented risk management solution that integrates the four key components of an effective Risk Evaluation and Mitigation Strategy (REMS): national, real-time, product-specific surveillance; signal detection; signal verification; and empirically validated prevention and intervention programs. NAVIPPRO began in 2001 with a series of grants from the National Institute on Drug Abuse (NIDA). In 2005, Endo Pharmaceuticals became the founding industry sponsor of NAVIPPRO and in 2006 Alpharma Pharmaceuticals LLC. (now King Pharmaceuticals, Inc.) became the second industry founder. Since that time, Shire Development, Inc. has joined in supporting the program, including providing founding sponsorship for the CHAT component. With NIDA’s continued support of ongoing research and product development, NAVIPPRO is constantly evolving to meet our goal of advancing public health. Learn more. Back to top		NAVIPPRO collects product–specific data on stimulant abuse FDA holds Advisory Committee meetings on Exalgo^™ and OxyContin^™ NDAs References About NAVIPPRO NAVIPPRO Surveillance Signal detection Signal verification Prevention & intervention ASI–MV Connect About Inflexxion Contact Contact us to find out how we can assist you with your risk evaluation and mitigation strategy planning. Subscribe Join the NAVIPPRO Signal mailing list. Support The NAVIPPRO team gratefully acknowledges the support of the NIH, King Pharmaceuticals, Inc., Endo Pharmaceuticals, and Shire Development, Inc.in the development of NAVIPPRO.

	The NAVIPPRO team gratefully acknowledges the support of the NIH, King Pharmaceuticals, Inc., Endo Pharmaceuticals, and Shire Development, Inc. in the development of NAVIPPRO. The contents of this newsletter are for informational purposes only and are not intended to be a substitute for professional medical advice, diagnosis or treatment. Reliance on any information provided in this newsletter is at your own risk. You should consult your physician or other qualified health provider if you have questions about a medical condition. If you think you have a medical emergency, call your doctor or 911 immediately. ©2009 Inflexxion, Inc. All rights reserved.