Acura, King Pharma announce positive topline results of Acurox tabs
Acura Pharmaceuticals, Inc and King Pharmaceuticals, Inc announced top-line results from Study AP-ADF-111 (Study 111) entitled 'A phase-II, Single-Center, Randomized, Double-Blind, Assessment of the Abuse Liability of Acurox (oxycodone HCl and niacin) tablets in subjects with a History of Opioid Abuse'. Study 111 results demonstrate that Acurox tablets are disliked compared to oxycodone HCl tablets alone when excess doses are swallowed. These results are statistically significant based on the dislike/like scores (p = .033), the primary measure of abuse deterrence potential for the study.
Acurox tablets contain a unique composition of oxycodone HCl, niacin, and essential functional inactive ingredients, and are intended to relieve moderate to severe pain while deterring common methods of prescription drug abuse. King and Acura entered into a license, development and commercialization agreement in October 2007. Based on this Agreement, the companies are jointly developing three immediate-release opioid analgesics using Acura's patented Aversion Technology and plan to submit an Acurox tablet New Drug Application (NDA) to the FDA later this year.
Opioid pain medicines developed with Aversion® Technology are intended to relieve moderate to severe pain while deterring common methods of prescription drug abuse including, intravenous injection of dissolved tablets, nasal snorting of crushed tablets and intentional swallowing of excess numbers of tablets.
King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company.
Acura Pharmaceuticals, Inc is a specialty pharmaceutical company engaged in research, development and manufacture of innovative Aversion® (abuse deterrent) Technology and related product candidates.