Welcome to the NAVIPPRO Signal.
Companies that develop, manufacture, and market opioids and stimulants are confronting extraordinary challenges in today's regulatory environment. One of the most critical is responding quickly and effectively as the FDA maps out new requirements for risk evaluation and mitigation strategies that can minimize the risk of adverse drug events, such as an emerging trend of misuse or abuse, while maximizing safe use.
On Tuesday, March 3rd, the FDA will meet with representatives from 15 manufacturers of extended-release (ER) opioid painkillers to initiate the process of developing a class-wide Risk Evaluation and Mitigation Strategy (REMS). Below, Kevin Zacharoff, M.D., Director of Medical Affairs at Inflexxion, offers his thoughts on what's at stake in the meeting and the implications moving forward for companies seeking to ensure the safe use of their products.
We hope you find this issue of NAVIPPRO Signal useful, and that you'll stay tuned for future issues as we explore developments that may change the shape of contemporary pharmaceutical risk management.
Sincerely,
The NAVIPPRO team
REMS: the next step in opioid risk minimization
Reflections on the road ahead
By Kevin Zacharoff, M.D.
In only a few short days, the FDA will meet with representatives from companies that manufacture 24 long-acting opioid medications to begin developing what’s expected to be a new, class-wide Risk Evaluation and Mitigation Strategy (REMS) program. The goal of REMS, broadly speaking, is to ensure that the benefits of certain products outweigh the risks: misuse, abuse, and overdose, both accidental and intentional. One of the key elements distinguishing REMS from the previous risk minimization action plans (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.
In this instance, the FDA has announced that it may require a REMS for products including extended-release (ER) versions of oxycodone, morphine, oxymorphone, and fentanyl, intended for around-the-clock pain relief. Notably, the list of products under consideration in the meeting do not include immediate-release opioids, which, based on data that we have gathered in the National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO), may actually represent a class of medications with a higher abuse potential than the ER formulations (see the graph below).
So what will the new program look like? The devil, of course, is in the details. In a call with the media on February 9th, John Jenkins, M.D., Director of the FDA's Office of New Drugs, stressed that the new REMS would be a "relatively massive new program," and that developing it would entail gathering input from multiple stakeholders, including patient and consumer advocates, pain and treatment communities, and other health professionals. He declined, however, to speculate on the shape the final program might take, leaving plenty of unanswered questions. Will the FDA issue guidance for creating individual REMS, or will the Agency require that companies work together to develop a single, class-wide REMS? If, as some have suggested, the new program adopts some elements from the iPLEDGE program for the acne treatment isotretinoin (Accutane), how might it differ?
While no one can answer these questions right now, it might help to look at the issue through the lens of the transition from RiskMAP to REMS.
In the case of opioid medications, the FDA has concluded that strategies for minimizing risk – which have included the RiskMAP – need to be more effective. As the FDA has stated, “Despite these efforts, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade.” Given iPLEDGE as a potential model for the new REMS program, raising the bar for efficacy will likely mean companies working more closely with diverse constituencies to mitigate risk. That includes physicians, pharmacists, patients – everyone along the continuum of care. To ensure that every link in the chain is strong, companies must take a comprehensive, integrated approach. And to make sure that risk-mitigation goals will be met, companies must build in ways of continuously, scientifically measuring the relative success or failure of their efforts. In short, they must facilitate the FDA’s goal of monitoring and reducing risk on a “real-time” basis, to the degree that is possible, without denying opioid medications to appropriate patient populations.
We at Inflexxion are committed to assisting all stakeholders – including the manufacturers, the FDA, and healthcare providers – in successfully navigating these issues and together improving the risk/benefit balance of opioid medications. We offer consultation, partnership in developing REMS, data collection and analysis, and educational programs that reach multiple constituencies. Our NAVIPPRO program integrates:
- Access to the largest, most accurate existing “real-time” proprietary data streams
- Advanced signal detection techniques
- Analysis of data and report generation
- Scientifically validated intervention, prevention, and educational programs to further education, and address detected signals in a targeted fashion
Our mission as a company is to improve health through technology, and we hope that through our work in REMS development, we can help ensure that patients are treated appropriately, with the best medications available, and the highest level of safety and vigilance.
If you would like to talk to us about NAVIPPRO and our experience working with companies to develop risk management plans, please feel free to contact me.
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. became the second industry founder. Since that time other pharmaceutical companies have become subscribers. With NIDA’s continued support of ongoing research and product development, NAVIPPRO is constantly evolving to meet our goal of advancing public health.
American Pain Society: 28th Annual Scientific Meeting
May 7, 2009 San Diego, California
The College on Problems of Drug Dependence: CPDD 71st Annual Meeting
June 20, 2009 Reno, Nevada
- NAVIPPRO
- Surveillance
- Signal detection
- Signal verification
- Prevention & intervention
- About Inflexxion
- FDA media release on ER opioid REMS
- List of affected opioid products
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Support
The NAVIPPRO team gratefully acknowledges the support of the NIH, Alpharma Pharmaceuticals LLC., and Endo Pharmaceuticals in the development of NAVIPPRO.
The NAVIPPRO team gratefully acknowledges the support of the NIH, Alpharma Pharmaceuticals LLC., and Endo Pharmaceuticals 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.
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