As part of the 3rd annual Human Abuse Liability & Abuse Deterrent Conference, Simon Budman, Chief Strategy Officer, will be presenting, “The Importance of Measuring Real World Abuse Deterrence of Generic Opioids: In Vitro and HAL Data is NOT Enough.” The conference is taking place November 2-3, in Arlington, VA. Read the abstract below to learn more about this powerful presentation.
Generic non-ADF products represent about 98% of the opioid market. The FDA is attempting to address this problem by encouraging generic manufacturers to produce ADF products and issuing new guidance in 2016 on measuring the abuse deterrent properties of these drugs. However, the recent guidance from the FDA on measuring abuse deterrence of generics does not address the desirability of Category 4 epidemiological studies for these products. Further, 2015 guidance from the FDA on the appearance of generics may make it very difficult to learn whether new generic ADFs are actually having a measurable impact and how they compare to the branded ADF.
This presentation will:
- Consider how abusers view generic opioids and the implications that this has for non-branded ADFs
- Discuss the absence of “real world” data when measuring abuse deterrence of generics
- Clarify the importance of drug distinguishability when measuring Category 4, “real world” abuse
- Examine the possible unintended consequences of ADF generics that look similar to the branded products, but are not required to produce epidemiological data