The abuse of prescription drugs is the fastest-growing drug problem in the United States, and reducing such abuse is a national priority. While the most prevalent route 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 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 opioid abuse epidemic, novel and effective technologies need to be developed and, ideally, applied widely to all prescription opioids to make them safer. Elysium?s O2P technology was designed to provide a balanced solution that takes advantage of the well-established efficacy of existing opioids, while protecting against abuse and fatal overdose. By using a novel chemistry approach, we have created a new class of immediate-release oral opioids that offer an attractive alternative to the widely- prescribed Vicodin, Percocet, Lortab, Norco, etc. This novel technology could (i) protect thousands of lives each year from fatal overdose; (ii) prevent the primary route of misuse and abuse of prescription opioids, and disrupt the heartbreaking and often lethal progression to illicit opioid (e.g. heroin, fentanyl) use and addiction; and (iii) provide safe and highly effective pain relief to patients. To that end, we have successfully completed the key aims of our previously awarded Phase II Fast-Track grant (1R44DA037900), and have identified clinical candidates that meet our target product profile and are ready to progress to IND-enabling activities. The strategic importance of this SBIR Phase I grant is to ensure that the cost-of-goods (COGs) associated with O2P opioids will facilitate their development and widespread use. In addition, we intend to deliver a cost effective, scalable, safe and robust API manufacturing process for the active pharmaceutical ingredients contained in both hydrocodone and oxycodone O2P drug products at kilogram scale. Further, it is anticipated that the successful completion of the proposed Aims will significantly reduce the time, costs and risks associated with the GMP manufacturing of APIs required for IND-enabling and Phase 1 human clinical studies, and provide critical information to potential commercialization partners.
Prescription opioids caused 18,893 overdose deaths in the United States in 2014, according to the American Society of Addiction Medicine. Elysium?s O2P (oral overdose protection) technology uniquely addresses a significant need of national importance by offering an innovative solution to reduce the risk of the oral and non-oral abuse of prescription opioids by (i) preventing the primary route of misuse and abuse of prescription opioids, (ii) disrupting the heartbreaking and often lethal progression to illicit opioid use (e.g. fentanyl and heroin) and addiction, and (iii) offering unprecedented protection from lethal oral overdoses of prescription opioids. The overall goal of this SBIR Phase I grant is to optimize chemistry processes and analytical methods to minimize the cost-of-goods (COGs) of our O2P opioids to facilitate their development and widespread commercial use.