Novel Opioid Prodrugs with Oral Overdose Protection: Minimizing Cost-of-Goods - Project Summary / Abstract
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.
