Novel Approaches to Drug Safety Surveillance Presented at 2009 College on Problems on Drug Dependence (CPDD) Conference
Newton, MA (PRWEB) June 18, 2009
On June 20-25, the College on Problems of Drug Dependence (CPDD) will hold its 71st Annual Meeting, bringing together research scientists and clinical investigators from diverse sectors to explore the biochemical, behavioral, and public health aspects of drug dependence. Inflexxion, a company that develops clinically validated solutions for critical areas of health care, will present research on new models and tools for monitoring the abuse of prescription pain medications, verifying the potential efficacy of new “abuse-deterrent” opioid formulations, and assessing and tracking behavioral health in adolescents.
“Prescription pain medication abuse is a national public health crisis that demands innovation,” says Kevin Zacharoff, M.D., Director of Medical Affairs at Inflexxion. “The CPDD conference provides an excellent forum for examining the science behind proposed solutions.”
Inflexxion, which has been recognized with a Tibbetts Award for its exemplary use of the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) grants, has integrated a number of its NIH-funded programs to create the National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO™). NAVIPPRO provides pharmaceutical companies with data and tools for implementing science-based, measurable Risk Evaluation and Mitigation Strategies (REMS) for opioid and stimulant medications. The program combines national, real-time, product-specific surveillance; signal detection; signal verification; and empirically validated prevention and intervention programs.
In late May, Inflexxion gave a presentation on NAVIPPRO at the FDA’s public meeting on developing REMS for certain extended-release opioid medications. At the forthcoming CPDD meeting, the company’s research scientists will provide details on findings from a series of investigations to test and refine components of the program, which is constantly evolving to meet public health goals.
“We’re examining critical questions in the development of systems for reducing prescription drug misuse, abuse, overdose, and deaths, while keeping valuable medications available to the patients who need them,” explains Dr. Zacharoff. “Can we use data collected from substance abuse treatment centers to link empirical patterns of drug abuse with such factors as geographic location and drug availability, so we can design targeted interventions? How does this data compare with data from other sources, and what are the implications for its utility in improving drug safety? What is the best way to gather timely, accurate information about how adolescents are abusing prescription drugs? And looking ahead, what are the appropriate models for measuring the potential efficacy of new ‘abuse-deterrent’ opioid formulations?”
Inflexxion has developed a scientific approach to establishing the abuse-deterrence profile of a particular prescription opioid medication, and recently published peer-reviewed commentary on the issues surrounding the development of abuse-deterrent formulations, entitled, “Can abuse-deterrent formulations make a difference? Expectation and speculation” (Harm Reduction Journal, Volume 8, Article 6).
Inflexxion’s research scientists will give four presentations on the company’s research at the CPDD conference, including a presentation on a model for evaluating an abuse-deterrent formulation’s potential public-health impact. They are:
“Geographic and contextual factors of prescription opioid abuse: Results from ASI-MV® Connect,” presented Monday, June 22, 8:45 a.m. (Oral Communications 3: “Prediction of Addiction”)
“Abuse Deterrent Adjusted Measurement Model: ADAMM™,” presented Monday, June 22, 9:15 a.m. (Oral Communications 3: “Prediction of Addiction”)
“Relative rates of prescription opioid abuse: Comparison of public health databases,” presented Monday, June 22, 10:00 a.m. (Oral Communications 7: “A Royal Flush of Prescription Opioid Epidemiology”)
“Validation of CHAT™: An interactive, multimedia scale to assess alcohol and substance addiction severity among adolescents,” Thursday, June 25, 8:00 a.m. – 9:00 a.m. (Poster Session IV: “Diagnosis and Assessment”)
In addition, Emil Chiauzzi, Ph.D., Vice President of Product Strategy at Inflexxion, will participate in a workshop entitled “Communicating the Risks of Opioid Analgesics: How Can We Do Better?” on Tuesday, June 23, from 8:00-9:00 p.m. Dr. Chiauzzi, the principal investigator of 25 SBIR grants, will discuss the Internet as a communication tool for conveying risk information concerning opioid analgesics, and examine how online tools might be best used and evaluated.
To learn more about Inflexxion, or to request a copy of a poster, please visit www.inflexxion.com and click on “Contact.”
To learn more about NAVIPPRO, please visit the website at www.navippro.com. Those interested in following developments in pharmaceutical risk management are welcome to sign up for “NAVIPPRO Signal,” a free monthly e-newsletter, at www.navippro.com/newsletter.
About Inflexxion
Founded in 1989, Inflexxion leverages technology to improve public health. We create clinically validated tools and programs for critical areas of health care, including prevention and wellness education, addiction and pain treatment, and pharmaceutical risk management. These innovative solutions help reduce health-related risks, enhance clinical outcomes, and positively impact the quality of care.
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