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
May 27. 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)) |
On May 27, 2014 we issued a press release announcingthatthe US Food and Drug Administration (FDA) advised us that the data from our intranasal abuse liability study AP-ADF-301 (Study 301) for our AVERSION® hydrocodone bitartrate with acetaminophen (hydrocodone/APAP) product candidate are insufficient to support an intranasal abuse deterrence claim and questioned whether the intranasal route is a relevant route of abuse for hydrocodone/APAP products and recommended we identify variables that could have impacted the findings from Study 301 before considering or conducting an additional intranasal abuse liability study on our AVERSION hydrocodone/APAP product. 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 May 27, 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: May 27, 2014
Exhibit Index
| Exhibit Number | | Description |
| | | |
| 99.1 | | Press Release dated May 27, 2014 |
