In the United States, there are currently more prescriptions for opioids than there are people. The number of deaths caused by drug overdoses continues to increase, with more than 60% involving prescription opioids. As a result, an estimated 42,000 people will be lost to the drug epidemic this year alone. What often begins as a temporary relief of pain can transition into an addiction that requires increased doses or a more efficient means of getting the drug into the person's system. Thus, patients have developed methods for processing the prescription pills to prepare them for alternative routes of administration such as injection, insufflation, or smoking. However, these alternative routes of administration can cause unsafe blood serum levels of the drug and lead to an overdose. Therefore, we propose to develop a novel abuse deterrent formulation (ADF) that will be uniquely designed to prevent abuse of the prescription pill. The proposal will be performed in 2 aims.
The first aim will focus on the development of the ADF formulation with design aspects specifically focused on abuse through insufflation, smoking, injection and taking multiple pills.
In Aim 2 we will focus on validating the design by putting the pill through a rigorous test following the procedures outlined by the FDA Abuse-Deterrent Opioids-Evaluation and Labeling guidelines. Our proposed studies will result in the development of a novel ADF formulation that will be resistant to a wide range of tampering, resulting in a safer formulation and pill design.
Opioid abuse is a growing U.S. epidemic that affects people regardless of their race, gender, or socioeconomic status. Individuals can abuse opioids by simply taking more than the prescribed dose, or by processing the pills for an alternative route of administration. This proposal will develop an abuse deterrent formulation designed to mitigate the pill processing schemes that facilitate abuse through insufflation, smoking, injection, or ingesting multiple capsules.
