Welcome to the NAVIPPRO Signal.
In January, the FDA released the Draft Guidance for Industry on Assessment of Abuse Potential of Drugs [PDF], and called for public comments to be submitted by March 29th, 2010.
The purpose of the draft guidance is to assist pharmaceutical companies that are developing drug products with the potential for abuse, clarifying issues such as what constitutes an adequate assessment of abuse potential. These issues are of special concern to companies developing drugs with so–called “abuse deterrent formulations,” or ADFs.
Inflexxion′s National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO) enables pharmaceutical companies to access “real–time,” product–specific data on the abuse of prescription drugs among sentinel populations, including data on the route of administration and the source of the drug. Below, we provide a brief summary of our response to the guidance, as well as a link to the full submission in the FDA docket.
We hope this issue of NAVIPPRO Signal is useful. If you have any questions about NAVIPPRO or our research, please feel free to contact us.
Sincerely,
The NAVIPPRO team
Assessment of abuse potential of drugs: Comments on FDA′s guidance for industry
Responding to the FDA′s call for comments on the Draft Guidance for Industry on Assessment of Abuse Potential of Drugs, Inflexxion has submitted comments to the docket. These comments detail our concerns with the approach that is outlined in the draft.
We point out that while pre–clinical, Phase I, II, and III studies are important for understanding the potential for a product to be abuse deterrent, the accurate assessment of abuse deterrence will require several measures of the post–market performance of a particular drug:
First of all, one must be able to measure whether the putative ADF is being abused. Having data at a compound level will not provide sufficient specificity for understanding how well a particular drug is performing.
Second, product availability is required in order to know whether there is a relationship between the amount of drug available for medical purposes and the level of abuse. (This relationship should be lower in an ADF than in a non-ADF product.)
Third, routes of administration for abuse of a particular ADF will make it clear whether abusers are able to ‘break’ the abuse deterrent mechanism or are just taking more drug than prescribed.
Finally, the closer to real time the data stream, the sooner the FDA and the public will know whether a particular ADF is working as it should, or has been ‘breached.’
You can download and read the complete submission [PDF]. If you have any questions about our comments or NAVIPPRO, please feel free to contact us.
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.
- NAVIPPRO
- Surveillance
- Signal detection
- Signal verification
- Prevention & intervention
- DETER Model
- 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.
©2010 Inflexxion, Inc. All rights reserved.
