FDA Meeting on Opioid REMS Highlights the Need for Comprehensive, Integrated Risk Management

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Inflexxion is uniquely positioned to assist companies with risk evaluation and mitigation strategy plans

One of the key elements distinguishing REMS from RiskMAPs is the requirement for ongoing evaluation of the efficacy of a program, both by the FDA and the sponsor of the drug, so adjustments can be made to ensure that risk-mitigation goals are being met

On Tuesday, March 3rd, the FDA will meet with manufacturers of extended-release (ER) opioid medications for what's expected to be the beginning of a process to develop a new Risk Evaluation and Mitigation Strategy (REMS) program. According to the Agency, strategies for minimizing the risks of opioid medications -- which have included FDA-required risk minimization and action plans, or RiskMAPs -- need to be strengthened.

"Despite [the efforts of the FDA, drug manufacturers, and other stakeholders], the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade," states the Agency in a media release announcing the meeting. Crafting a new REMS program, the Agency says, will entail "discussions with other federal agencies and non-government institutions, including patient and consumer advocates, representatives of the pain and addiction treatment communities, other health care professionals, and other interested parties."

Inflexxion, a company that is deeply engaged with the pain and addiction treatment communities, is uniquely prepared to assist manufacturers, federal agencies, and other stakeholders with creating a comprehensive REMS. In 2001, the company's pharmaceutical risk-management division launched development of the National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO) with support from the National Institutes of Health (NIH). Now a nationally recognized public health-oriented substance risk management solution, NAVIPPRO integrates the four key components of an effective REMS: national, "real-time," product-specific surveillance; signal detection; signal verification; and empirically validated prevention and intervention programs.

"One of the key elements distinguishing REMS from RiskMAPs is the requirement for ongoing evaluation of the efficacy of a program, both by the FDA and the sponsor of the drug, so adjustments can be made to ensure that risk-mitigation goals are being met," says Kevin Zacharoff, M.D., Director of Medical Affairs at Inflexxion. "NAVIPPRO is designed to assist with this type of long-term, continuous evaluation."

In a recent study of NAVIPPRO data published in Pharmacoepidemiology and Drug Safety (December 2008, Volume 17, Issue 12), the authors evaluated the surveillance component of the program. Analyzing NAVIPPRO's proprietary, "real-time" data stream, de-identified client assessment data continuously collected from the ASI-MV® Connect network of substance abuse clinics across the U.S., they examined the representativeness, geographic coverage, and timeliness of report of the data. They found that the data allow for the characterization of product-specific and geo-spatial differences for drug abuse, and can serve as a tool for monitoring the responses of the treatment center population to particular drug formulations.

According to Zacharoff, the findings show that NAVIPPRO data can be useful for measuring, in "real time," the relative rate of abuse of a particular drug in a vulnerable population, and in a specific geographic area of the country. "These data can help detect early signals of an emerging trend of abuse, which in turn allows for targeted prevention and intervention efforts, and for gauging the impact of those initiatives," he says.

To address the need for prevention and intervention, Inflexxion has incorporated into NAVIPPRO its award-winning, empirically validated educational programs. These programs include PainEDU.org, a comprehensive pain education website for health care professionals with nearly 20,000 subscribed clinicians of varying disciplines. As part of its educational offerings, PainEDU provides clinicians with access to clinically tested practice tools, such as the Screener and Opioid Assessment for Patients with Pain (SOAPP®).

Developed by Inflexxion, SOAPP is a brief, pen-and-paper self-report tool that enables health care providers to assess a patient's risk of addiction before initiating opioid therapy. It can be used in concert with the Current Opioid Misuse Measure (COMM)®, a complementary tool for identifying whether a patient, throughout the course of long-term opioid therapy, may be exhibiting aberrant behaviors associated with abuse of opioid medications.

The utility of SOAPP and COMM were recently highlighted in new guidelines by the American Pain Society and the American Academy of Pain Medicine on the use of opioid medications to treat chronic non-cancer pain. The guidelines, published in the February 2009 issue of The Journal of Pain (Volume 10, Number 2), recommend that clinicians routinely conduct a complete benefit-to-harm evaluation before starting opioid therapy, and do periodic follow-up screenings of patients who may be at risk for abuse or addiction.

"In the past, drug sponsors and consultants worked individually on programs designed to minimize risk in a hit-or-miss fashion, with very little modification of the initiatives based on outcomes. I believe that the FDA hopes that this new REMS development process will provide an opportunity for these groups to come together, working more closely to ensure that patients are treated appropriately, based on collected data, with the best medications available, and the highest level of safety and vigilance," says Zacharoff. "We at Inflexxion are committed to assisting all stakeholders - including the manufacturers, the FDA, and health care providers - in successfully navigating these issues and together improving the risk-benefit balance of opioid medications."

To learn more about NAVIPPRO, visit the website (http://www.navippro.com).

About Inflexxion, Inc.

Founded in 1989, Inflexxion creates innovative, award-winning behavioral health solutions for prevention, education, and disease management. Our grant-funded, clinically tested programs address substance abuse and addiction, chronic pain management, and other health and wellness issues. Our pharmaceutical risk management division provides Risk Evaluation and Mitigation Strategy (REMS) assistance to companies that research, manufacture, and market opioid pain medications and other therapeutic agents with potential abuse problems. Key offerings include NAVIPPROTM, ASI-MV® Connect, PainEDU.org, painACTION.com, and SOAPP®. Inflexxion is based in Newton, MA.

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Amanda Hemm
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