The abuse of prescription drugs is the fastest-growing drug problem in the United States, and reducing such abuse is a national priority. While one of the most prevalent routes of abuse for opioid medicines is the oral route, current formulation- and molecular-based technologies are primarily designed to resist abuse via non-oral routes (e.g., inhalation and injection). Consequently, these approaches fail to adequately address oral abuse and overdose (i.e., co-ingestion of multiple pills), and can be easily thwarted by straightforward extraction techniques. To address the nation's prescription drug misuse, abuse, and overdose epidemics, comprehensive, robust abuse-resistance technologies need to be developed and, ideally, applied to all prescription opioid drugs. To that end, we propose to qualify at least one product candidate for IND-enabling studies from a unique class of proprietary molecules designed to provide effective opioid-based pain relief, with unprecedented protection from all routes of abuse. We are applying for Fast-Track because NIDA program officials assured us that our proposed project is an excellent Fast-Track candidate based on: Compelling in vitro and in vivo data from studies led by our Principal Investigator demonstrate feasibility; Current formulation-based technologies do not effectively address oral misuse, abuse, and overdose; and Key stakeholders (i.e., potential large pharmaceutical partners - for development and commercialization, key opinion leaders, prescribing physicians, and patients) have expressed strong interest in our technology.
The entwined epidemics of prescription opioid abuse and undertreated pain have given rise to the need for pain therapies that are less likely to be abused. While one of the most prevalent routes of abuse for opioid medicines is the oral route, no technologies have been developed to protect against overdose from the co- ingestion of multiple pills ('oral overdose'). Elysium has discovered a unique class of proprietary molecules designed to provide effective opioid-based pain relief, with unprecedented protection from all routes of abuse.
