Acura Pharmaceuticals to Develop Abuse Deterrent Hydrocodone With Acetaminophen Tablets With Limitx Technology

Acura Pharmaceuticals Inc. ACUR, announced today that it is initiating development of an immediate-release hydrocodone bitartrate with acetaminophen tablet ("hydrocodone/APAP") incorporating Acura's novel LIMITX™ abuse deterrent technology. Hydrocodone/APAP, with over 135 million dispensed prescriptions in 2014 in the United States, is the largest prescribed opioid to treat moderate to severe pain. It also is the single most abused prescription opioid, predominately by swallowing multiple tablets. LIMITX is designed specifically to address this route of abuse. The Food and Drug Administration's (FDA) April 2015 Abuse-Deterrent Opioids Evaluation and Labeling Guidance singles out immediate-release combination opioids with acetaminophen as being predominately abused by the oral route and that reducing nasal snorting of these products may not be meaningful. Development of the Company's LIMITX technology is currently being supported by a grant from the National Institute on Drug Abuse of the National Institutes of Health (NIH) to develop an immediate-release hydromorphone tablet. The Company intends to initiate formulation development of the LIMITX hydrocodone/APAP tablet upon the conclusion of formulation optimization of the LIMITX hydromorphone product. Acura had previously advanced the development of a hydrocodone/APAP product using our AVERSION® technology, which was designed to deter nasal snorting, but intends to indefinitely suspend those efforts. "Based on the recent FDA Guidance as well as comments made by the former-FDA Commissioner at a March 2015 Appropriation Hearing, we believe the best course for Acura is to develop immediate-release acetaminophen combination opioids with our novel LIMITX technology", said Bob Jones, President and CEO of Acura. "We are pleased to be partnered with the NIH on our LIMITX technology and believe it may also be applicable to snorting abuse, which we continue to believe is a route of abuse for these products that needs addressing."