A proposal to develop a self-regulating hydromorphone tablet to deter excess oral

DESCRIPTION: The medical misuse and non-medical use of prescription opioid analgesics is a significant problem in USA and its societal effects and cost have been well documented. The emergence of abuse deterrent opioid products into the marketplace is targeted to stem the advance of this complex problem. Although new abuse deterrent opioid products have been introduced which deter manipulation of the product for intravenous and intranasal routes of administration, none of the currently marketed abuse deterrent products address the most prevalent route of opioid misuse and abuse, excess oral consumption. The recent FDA guidance on abuse deterrent opioids clearly notes the lack of an abuse deterrent technology to deter excess oral consumption. Acura Pharmaceuticals Inc. (Acura) is a small specialty pharmaceutical company focused on the development and commercialization of abuse deterrent products to deter medication abuse and misuse. Acura's Aversion(R) technology is contained in Pfizer's Oxecta immediate relea