New Publication Describes Program for Monitoring Prescription Drug Abuse, Managing Risk

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NAVIPPRO(TM) provides "real-time," product-specific surveillance data for scheduled therapeutics

Data collected by this network allow for the characterization of product-specific and geospatial differences in drug abuse, and can serve as a tool for monitoring the impact among the treatment center population of newly developed drug formulations.

Inflexxion Inc., a company that creates scientifically validated and cost-effective solutions for critical areas of health care, is pleased to announce the publication of a study evaluating a core component of the National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO). NAVIPPRO is a comprehensive risk management program for post-marketing surveillance of Schedule II and III medications. The program monitors, on an active, ongoing basis, indicators of adverse drug events, such as an emerging trend of abuse.

The article, entitled "National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO): A real-time, product-specific, public health surveillance system for monitoring prescription drug abuse," appears in Pharmacoepidemiology and Drug Safety (December 2008, Volume 17, Issue 12, Pages: 1142-1154). It is authored by Stephen F. Butler, Simon H. Budman, Andrea Licari, Theresa A. Cassidy, Katherine Lioy, James Dickinson, John S. Brownstein, James C. Benneyan, Traci Craig Green, and Nathaniel Katz.

"The recent announcement from the FDA that the Agency will require companies with extended-release opioids to develop a class-wide, common Risk Evaluation and Mitigation Strategy (REMS) highlights the need for comprehensive, science-based pharmaceutical risk management," says Simon Budman, Ph.D., co-author of the study and Founder, President, and CEO of Inflexxion. "NAVIPPRO enables companies to track the abuse of all branded and generic prescription opioids in real-time, against a standard metric. It also provides tools for mitigating risk, such as PainEDU and painACTION, empirically tested programs that help clinicians and patients better understand appropriate, safe use of opioids."

NAVIPPRO integrates the key components of an effective REMS: national, real-time, product-specific surveillance; signal detection; signal verification; and empirically validated prevention and intervention programs. The study focuses on the ASI-MV® Connect surveillance component of the program, which includes the collection and analysis of "real-time" data from a network of substance abuse clinics across the United States.

"We examined client data collected on 41,923 admissions to 265 substance abuse clinics in 29 states, and assessed the representativeness, geographic coverage, and timeliness of report of the data," says Stephen Butler, Ph.D., lead author of the study, Chief Science Officer and Senior Vice President of Inflexxion. "Data collected by this network allow for the characterization of product-specific and geospatial differences in drug abuse, and can serve as a tool for monitoring the impact among the treatment center population of newly developed drug formulations."

NAVIPPRO was developed by Inflexxion with support from the National Institute on Drug Abuse (NIDA), and industry support from Endo Pharmaceuticals, Inc. and Alpharma Pharmaceuticals LLC. With our ongoing research and product development, NAVIPPRO is constantly evolving to meet Inflexxion's goal of advancing public health. To learn more about the program, visit the NAVIPPRO website (http://www.navippro.com).

About Inflexxion, Inc.
Founded in 1989, Inflexxion creates behavioral health solutions for prevention, education, and disease management. Inflexxion develops clinically tested programs for substance abuse and addiction, cancer, HIV, chronic pain management, women's health, and other health and wellness issues. These innovative programs help health professionals, pharmaceutical companies, and biotechnology firms deliver quality care to diverse populations. Our risk management division builds custom tools, products, and services to support the risk management initiatives of companies that research, manufacture, and market opioid pain medications and other therapeutic agents with potential abuse problems. Key offerings include NAVIPPRO, PainEDU.org, painACTION.com, and SOAPP®. Inflexxion is based in Newton, MA.

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Lara Romanowski
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