Substance Abuse Treatment Center Data

According to the FDA's Guidance for Industry: Abuse-Deterrent Opioids — Evaluation and Labeling, finalized in 2015, post-marketing epidemiological evaluations of the potential abuse deterrent properties of a product require "a variety of sources" of drug abuse data. This reflects the FDA's appreciation that no single data stream alone will capture all relevant data necessary to adequately evaluate misuse and abuse of prescription opioids, specifically citing "known drug abusers." While there are a variety of ways to access these populations of "known drug abusers," those in substance abuse treatment provide a source of data that has certain advantages.

Capturing self-reports of recent (past 30-day) abuse from those being evaluated for substance use problems allows the rapid assessment of large numbers of people. This population can be considered to be "saturated" in that it consists of individuals that are more likely to have access to and perhaps actively seek to find new or difficult-to-find products. This population may also be more likely to tamper with and use (or try to use) an alternate ROA (e.g., snorting and injection) and these individuals may be considered among the "early adopters" in the drug-abuse world. Furthermore, the concentration of high-risk individuals permits the early detection of specified abuse patterns, potentially before these emerge in a detectable way within the general population.

Inflexxion's ASI-MV® and BHI-MV™ data streams offer a number of advantages for collecting data from individuals being evaluated in this context on specific prescription opioid products in a comprehensive, practical, and timely way. The ASI-MV/BHI-MV data stream collects approximately 15,000 new substance abuse treatment evaluations per quarter in near real-time, and at a product-specific level. Such data allow Inflexxion's scientists to design epidemiology studies that are unique in the industry, providing the relevant variables and statistical power to test hypotheses.

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