Attached files
| file | filename |
|---|---|
| EX-99.1 - EXHIBIT 99.1 - ACURA PHARMACEUTICALS, INC | v389101_ex99-1.htm |
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
September 15, 2014
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 | (Commission File Number) | (I.R.S. Employer |
| of Incorporation) | 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 (17CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17CFR240.14d- 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 September 15, 2014 we issued a press release regarding our submission of a formal dispute resolution request with the US Food and Drug Administration (FDA) regarding Vycavert®, our AVERSION® hydrocodone with acetaminophen tablet development candidate. The dispute pertains to the FDA’s determination that nasal snorting abuse of hydrocodone with acetaminophen products lacks relevance, thus making Vycavert® ineligible for abuse-deterrent labeling regardless of its abuse-deterrent profile.
The press release is attached hereto and filed as Exhibit 99.1.
| Item 9.01 | Financial Statements and Exhibits |
| Exhibit Number | Description |
| 99.1 | Press Release dated September 15, 2014 |
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 A. Clemens | |
| Peter A. Clemens Senior Vice President & Chief Financial Officer | ||
Date: September 15, 2014
Exhibit Index
| Exhibit Number | Description |
| 99.1 | Press Release dated September 15, 2014 |