Sep. 3, 2009 (Business Wire) -- Acura Pharmaceuticals, Inc. (NASDAQ: ACUR) and King Pharmaceuticals, Inc. (NYSE: KG) announced today that they met with the U.S. Food and Drug Administration ("FDA") on September 2, 2009 to discuss the FDA’s June 30, 2009 Complete Response Letter regarding the New Drug Application for Acurox^® (oxycodone HCl and niacin) Tablets CII (NDA). The FDA and the Companies agreed to take the NDA to an FDA Advisory Committee to consider the evidence to support the potential opioid abuse deterrent effects of Acurox^® Tablets. The FDA indicated that no new clinical trials are required at this time. The FDA has not yet set a meeting date for the Advisory Committee’s review of the NDA. The Companies do not expect the meeting to be convened before the end of this year.

About ACUROX^® Tablets

ACUROX^® is an investigational, patented, orally administered, immediate release tablet containing oxycodone HCl as its sole active analgesic ingredient with a proposed indication for the relief of moderate-to-severe pain. ACUROX^® utilizes Acura’s proprietary Aversion^® Technology, which is designed to discourage some common methods of misuse and abuse. The clinical significance of Aversion^® Technology has not been established.

About Acura Pharmaceuticals, Inc.

Acura Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in research, development and manufacture of innovative Aversion^® (abuse deterrent) Technology and related product candidates. Acura entered into a License, Development and Commercialization Agreement with King Pharmaceuticals Research and Development, Inc. (“King”), a wholly-owned subsidiary of King Pharmaceuticals, Inc., in October 2007 pursuant to which Acura and King are now jointly developing ACUROX^® Tablets and three additional opioid analgesic product candidates utilizing Aversion^® Technology.

About King Pharmaceuticals, Inc.

King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products and technologies that complement the Company’s focus in specialty-driven markets, particularly neuroscience and hospital. King’s wholly owned subsidiary, Alpharma Inc., is also a leader in the development, registration, manufacture, and marketing of pharmaceutical products for food-producing animals.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "Act").