Acura Pharmaceuticals Provides Update on Its Hydrocodone Bitartrate With Acetaminophen Tablets Development

PALATINE, IL--(Marketwired - October 16, 2014) - Acura Pharmaceuticals Inc. (NASDAQ: ACUR) announced today that the US Food and Drug Administration (FDA) has denied on procedural grounds Acura's appeal of the position taken by Division of Anesthesia, Analgesia, and Addiction Products (DAAAP) that abuse by snorting of hydrocodone with acetaminophen products lacks relevance. Relevance is defined in FDA's January 2013 Draft Guidance on the evaluation and labeling of abuse deterrent opioids to be a "known or expected" route of abuse for that product.

In a letter decision from the Office of Drug Evaluation II, the FDA indicated that DAAAP's comments and correspondence to date with Acura, as well as the Draft Guidance on abuse deterrent opioids, should be viewed only as recommendations and opinions and do not preclude Acura from completing its clinical development and submitting a New Drug Application for its hydrocodone with acetaminophen product for consideration. FDA further noted that for issues such as abuse-deterrence an Advisory Committee meeting may greatly inform their considerations.

The FDA's letter also advised the Company that we may appeal this decision to the next level within the FDA. Acura is assessing its development strategy for its abuse deterrent hydrocodone with acetaminophen program, including the merits of appealing the FDA's decision.

Bob Jones, Acura's CEO, stated, "We're frustrated that the FDA chose not to make a decision on the fundamental question of whether nasal abuse of hydrocodone/acetaminophen products constitutes a 'relevant' public health issue that should be addressed by the development of abuse-deterrent versions of this drug, even with all known information at its disposal. However, we are encouraged that the FDA has demonstrated a willingness to seek advice on the issue of 'relevance' from an Advisory Committee when such critical public health issues are at stake."

About Acura Pharmaceuticals
Acura Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development and commercialization of product candidates intended to address medication abuse and misuse, utilizing its proprietary LIMITX™, AVERSION® and IMPEDE® Technologies. LIMITX™ contains ingredients that are intended to reduce or limit the rate or extent of opioid release when multiple tablets are ingested. AVERSION® contains polymers that cause the drug to gel when dissolved; it also contains compounds that irritate the nasal passages if the product is snorted. IMPEDE® is designed to disrupt the processing of pseudoephedrine from tablets into methamphetamine.