Approved labeling for tamper-resistant opioid formulations could rest on Web monitoring of drug abusers

Inflexxion, a risk-management service provider, assists manufacturers seeking FDA approval for new medical claims, and for helping manufacturers, providers and institutions cope with abuse of prescription drugs, including pain meds, stimulants and other DEA Schedule 2 and 3 drugs. According to Dr. Simon Budman, founder and CEO of the Newton, MA, company, Inflexxion is currently assisting extended-release opioid manufacturers with gaining approval for new label claims for quantifiable data on the tamper resistant formulations now coming on the market. “Pharma companies have invested time and money in these tamper-resistant technologies, and they want to be able to make a claim on the product label to that effect. But FDA is struggling with how to justify the proof of such claims.”

At a recent FDA advisory meeting, Inflexxion and its pharma clients proposed using two data streams within its the National Addictions Vigilance Intervention and Prevention Program (Navippro). One is the Addiction Severity Index (ASI); the other is an online monitoring service called Web Informed Services (WIS). Navippro data is generated primarily the hospitals and treatment centers; Navippro provdes a structure to patient data collection and for analyzing what drugs are being abused; WIS, according to Budman, has been used for the past four years “to monitor what is being said about drug use in online forums and Web postings,” adding that “the logic of crowd-sourcing helps distinguish between actual abuse and people just making claims on how they got high.” Together, these data streams provide a near real-time measure of what is happening among drug abusers, and in theory could confirm or disprove the tamper resistance of new drugs and thereby give FDA the evidence it requires to justify a label claim.

Inflexxion is also working with several drugmakers on dealing with FDA’s call for a class-wide Risk Evaluation and Mitigation Strategy for extended release opioids.