This article focused on abuse-deterrent formulations or ADFs of various drug products. Opioid pain relievers are highly abused, with the highest percent of abuse found in pain clinics (8 to 16%). Abusers are known to tamper with the original drug product through various means that include crushing the tablet, administering rectally, combining with alcohol, smoking, and more. The FDA hopes that by regulating the design or both pre and post-marketing studies they will be able to encourage ADFs. Ways in which to make a drug in an abuse-deterrent form is by rendering the drug inactive when tampered with. The product could also be formulated with physiochemical barriers to abuse. Various post-marketing studies will determine whether the completed product actually results in meaningful abuse reductions. Current ADF products include oxycodone with Intac technology, which requires an excessive amount of force to crush or break the tablet. Also, when this formulation comes into contact with water, it transforms into a consistency that can not be drawn into a syringe.
While these formulations have proven to decrease abuse rates in patients seeking pain management, the cost burden might affect the availability for patients at risk of abuse. Most of these products are only available as brand name products, as generic opioids are not in ADF form. In our Drug Development class we have learned a lot about the drug development process when it comes to brand versus generic formulation. How long will it take for these formulations to become available? What barriers might patients face to obtain these products and what are some possible solutions? The article brings up a good point of offering savings cards or coupons for these products. Would this encourage ADFs over regularly formulated opioid pain relievers?
Nguyen V, Raffa RB, Taylor R. The role of abuse-deterrent formulations in countering opioid misuse and abuse. J Clin Pharm Ther. 2015; 40:629-34.