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
August 6, 2009
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 |
(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:
________________________________________________________________________________
(Former name or former address, if changed since last report)
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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 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01. Other Events.
On August 6, 2009 we issued the attached press release, announcing that we submitted a briefing package to the U.S. Food and Drug Administration ("FDA") addressing the issues raised in the FDA's June 30, 2009 Complete Response Letter ("CRL") related to the New Drug Application ("NDA") for Acurox® (oxycodone HCl/niacin) Tablets and also announcing that we and King Pharmaceuticals Research and Development, Inc ("King"), are scheduled to meet with the FDA in late third quarter 2009 to discuss the CRL and the briefing package.
We are a party to an exclusive License Agreement with King Pharmaceuticals Research and Development, Inc., a subsidiary of King Pharmaceuticals, Inc., for the development and commercialization of certain opioid analgesic products utilizing our Aversion® Technology in the United States, Canada and Mexico. The License Agreement provides King with an exclusive license for Acurox® Tablets® and three additional opioid analgesic products utilizing Aversion® Technology.
Item 9.01. Financial Statements and Exhibits.
Exhibit
Number | | Description |
| |
| 99.1 | Press Release dated August 6, 2009 |
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.
|
| Date: August 6, 2009 | By: | /s/ PETER A. CLEMENS
Peter A. Clemens
Senior Vice President & Chief Financial Officer |
EXHIBIT INDEX
Exhibit
Number | | Description |
| |
| 99.1 | Press Release dated August 6, 2009 |
