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
March 15, 2010
Date of Report (Date of earliest event reported)
Acura Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
State of New York |
1-10113 |
11-0853640 |
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(State or other jurisdiction of incorporation) |
(Commission File Number) | (IRS Employer Identification No.) |
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): |
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[ ] | 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 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01. Other Events.
On March 15, 2010, we issued a press release, attached hereto as Exhibit 99.1, announcing clinical evaluation is now allowed under an Investigational New Drug application filed with the U.S. Food and Drug Administration for a benzodiazepine product candidate utilizing our Aversion® technology.
Item 9.01. Financial Statements and Exhibits.
Exhibit Number
Description
99.1
Press Release dated March 15, 2010.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Acura Pharmaceuticals, Inc. |
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Date: March 15, 2010 | By: | /s/ PETER A. CLEMENS Peter A. Clemens Senior Vice President & Chief Financial Officer |
EXHIBIT INDEX
Exhibit Number |
Description | |
99.1 | Press Release dated March 15, 2010. |
EXHIBIT 99.1
PALATINE, Ill., March 15, 2010 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (Nasdaq:ACUR) today announced clinical evaluation is now allowed under an Investigational New Drug application ("IND") filed with the U.S. Food and Drug Administration ("FDA") for a benzodiazepine product candidate utilizing our Aversion® Technology. The primary active ingredient in this product candidate is intended for the treatment of anxiety disorders. Aversion® Technology is a unique mixture of active and functional inactive ingredients, intended to minimize abuse liability potential of the primary active ingredient. Benzodiazepine products are classified as Schedule IV for potential abuse by the U.S. Drug Enforcement Administration ("DEA"). Acura has now opened three INDs for Aversion® Technology product candidates.
According to Drugs of Abuse, published by the DEA, tranquilizers, which include benzodiazepines, are abused in manners similar to opioid analgesics. The 2008 National Survey on Drug Use and Health estimates that 21.5 million people have abused prescription tranquilizers at some point in their lifetime and 5.1 million have abused tranquilizers in the past year.
About Acura Pharmaceuticals
Acura Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in research, development and manufacture of product candidates providing limits or impediments to abuse utilizing our proprietary Aversion® Technology, Impede™ Technology, and other novel technologies.
The Acura Pharmaceuticals, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=4847
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 the development and FDA approval of our product candidates and the market acceptance for our product candidates if approved. Acura Pharmaceuticals, Inc. disclaims 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, performan ce, 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 the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2009, which is on file with the U.S. Securities and Exchange Commission.
CONTACT: Acura Pharmaceuticals, Inc. Peter A. Clemens, SVP & CFO 847-705-7709