UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D. C. 20549
____________
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act Of 1934
April 22, 2010
Date of Report (Date of earliest event reported)
___________________________________________________________
ACURA PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
___________________________________________________________
|
State of New York |
1-10113 |
11-0853640 |
|
(State of Other Jurisdiction
of Incorporation) |
(Commission File Number) |
(I.R.S. Employer
Identification Number) |
616 N. North Court, Suite 120
Palatine, Illinois 60067
(Address of principal executive offices) (Zip Code)
(847) 705-7709
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17CFR 240.13e-4(c))
|
Item 8.01 |
Other Events |
On April 22, 2010 we issued a press release relating to a vote taken by the Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees to the Food and Drug Administration at their joint meeting held April 22, 2010, relating to the New Drug Application for Acurox®
(oxycodone HCl and niacin) Tablets. A copy of our press release is attached as Exhibit 99.1 hereto and is incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits
Exhibit Number Description
|
99.1 |
Press Release dated April 22, 2010 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
ACURA PHARMACEUTICALS, INC.
By: /s/ Peter Clemens
Peter A. Clemens
Senior Vice President & Chief Financial Officer
Date: April 22, 2010
EXHIBIT INDEX
Exhibit Number Description
|
99.1 |
Press Release dated April 22, 2010 |
King Pharmaceuticals Contacts:
Investors:
Jack Howarth, Vice President, Investor Relations
908-429-8350
Acura Pharmaceuticals Contact:
Peter Clemens, SVP & CFO
847-705-7709
Media Contact:
Laurie Masonson, Ruder Finn, Inc.
212-583-2793
ACURA PHARMACEUTICALS AND KING PHARMACEUTICALS PROVIDE UPDATE ON FDA ADVISORY COMMITTEE MEETING FOR ACUROX®
PALATINE, ILLINOIS and BRISTOL, TENNESSEE, April 22, 2010 — Acura Pharmaceuticals, Inc. (NASDAQ: ACUR) and King Pharmaceuticals®, Inc. (NYSE: KG) today announced that the U.S. Food and Drug Administration's
(FDA) Anesthetic and Life Support Drugs and Drug Safety and Risk Management Committees voted that they do not have enough evidence to support the approval of the New Drug Application (NDA) for Acurox® (oxycodone HC1 and niacin) Tablets for the treatment of moderate to severe pain, considering the deterrent effects of niacin as well as the potential deterrent effects of the other features specific to Acurox®. The
addition of niacin to Acurox® was central to the deliberations. The FDA is not bound by the Advisory Committees’ recommendation, but may take its advice into consideration when evaluating the NDA for Acurox® Tablets. Acura and King will work with the FDA to determine the next steps for the Acurox® development
program.
About Acurox®
Acurox® is an investigational immediate-release product containing two active ingredients and essential functional inactive ingredients. Each Acurox® tablet contains oxycodone
HCl as the sole active analgesic ingredient. Niacin, the second active ingredient, is intended to minimize the potential for oral abuse of oxycodone HCl. The functional excipients are intended to provide limits and impediments to the abuse of Acurox® Tablets by snorting and intravenous methods. Both oxycodone HCl and niacin are FDA-approved drugs with extensive clinical experience and well-characterized safety profiles.
About Acura Pharmaceuticals, Inc.
Acura Pharmaceuticals, Inc., is a specialty pharmaceutical company engaged in research, development and manufacture of product candidates intended to provide abuse-deterrent features and benefits utilizing the Company’s proprietary Aversion® Technology,
Impede™ Technology, and other novel technologies. Acura entered into a License, Development and Commercialization Agreement with King Pharmaceuticals®, Inc., in October 2009 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.
Related links:
http://www.AcuraPharm.com
http://www.KingPharm.com
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "Act"). When used in this press release, the words "estimate," "project," "anticipate," "expect," "intend," "believe," and similar expressions are intended to identify forward-looking statements.
Examples of forward-looking statements in this press release include statements concerning the Companies’ expectations regarding working with the FDA. Acura Pharmaceuticals, Inc. and King Pharmaceuticals, Inc. disclaim any intent or obligation to update these forward-looking statements, and claim the protection of the Safe Harbor for forward-looking statements contained in the Act. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which
may cause actual results, performance or achievements to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Important factors that may cause actual results to differ materially from the forward-looking statements are discussed in the “Risk Factors” section and other sections of each of the Companies’ Annual Reports on Form 10-K for the fiscal year ended December 31, 2009, each of which is on file with the U.S.
Securities and Exchange Commission.
EXECUTIVE OFFICES
ACURA PHARMACEUTICALS, INC.
616 N. NORTH COURT, PALATINE, ILLINOIS 60067
KING PHARMACEUTICALS®, INC.
501 FIFTH STREET, BRISTOL, TN 37620
IMPEDE is a trademark and ACUROX and AVERSION are registered trademarks of Acura Pharmaceuticals, Inc.
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