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
June
2,
2008
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):
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o Soliciting
material pursuant to Rule 14a-12
under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement
communications pursuant to
Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d- 2(b))
o Pre-commencement
communications pursuant to
Rule 13e-4(c) under the Exchange Act (17CFR 240.13e- 4(c))
Item
8.01 Other
Events
On
June
2, 2008 Acura
Pharmaceuticals, Inc. (“Acura”) issued the attached press release being
furnished as Exhibit 99.1, announcing that clinical evaluation is now permitted
under an active Investigational New Drug application for a certain opioid
analgesic product candidate using Aversion®
technology, previously licensed by Acura to King Pharmaceuticals Research and
Development, Inc., a wholly owned subsidiary of King Pharmaceuticals,
Inc.
Item
9.01 Financial
Statements and Exhibits
| Exhibit Number |
Description
|
| 99.1 | Press Release of the Registrant dated June 2, 2008. |
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: June 2, 2008
EXHIBIT
INDEX
| Exhibit Number |
Description
|
| 99.1 | Press Release of the Registrant dated June 2, 2008. |
 |
Acura
Pharmaceuticals Contact:
Peter
A. Clemens, SVP Investor Relations & CFO
847-705-7709
|
ACURA
PHARMACEUTICALS, INC.
ANNOUNCES
ACTIVE IND FOR SECOND OPIOID ANALGESIC PRODUCT CANDIDATE USING AVERSION®
TECHNOLOGY
PALATINE,
ILLINOIS, June
2,
2008 -
Acura Pharmaceuticals, Inc. (NASDAQ: ACUR) today announced
that
clinical evaluation is now allowed under an active Investigational New Drug
application (“IND”) for a
second
undisclosed opioid analgesic product candidate using Aversion®
Technology. This product candidate was previously licensed by Acura to King
Pharmaceuticals Research and Development, Inc., a wholly owned subsidiary of
King Pharmaceuticals, Inc. ("King") as a result of the License, Development
and
Commercialization Agreement between the companies. Acura and King are jointly
developing opioid analgesic product candidates utilizing Acura’s proprietary
Aversion®
Technology. These product candidates are intended to deter common methods of
prescription drug misuse and abuse.
About
Acura Pharmaceuticals
Acura
Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in research,
development and manufacture of innovative Aversion®
(abuse
deterrent) Technology and related product candidates.
Forward-looking
Statements
This
release contains forward-looking statements which reflect management’s current
views of future events and operations, including, but not limited to, plans
to
develop immediate-release opioid analgesic products utilizing Acura’s
proprietary Aversion® Technology platform. These forward-looking statements
involve certain significant risks and uncertainties, and actual results may
differ materially from the forward-looking statements. Some important factors
which may cause actual results to differ materially from the forward-looking
statements include dependence on the
Company’s ability to continue to advance the development of its pipeline
products as planned; dependence on the high cost and uncertainty of research,
clinical trials, and other development activities involving pharmaceutical
products in which the company has an interest; dependence on the
unpredictability of the duration and results of the U.S. Food and Drug
Administration review of Investigational New Drug applications, New Drug
Applications and/or the review of other regulatory agencies worldwide that
relate to products in development; dependence on the availability and cost
of
raw materials; dependence on no material interruptions in supply by contract
manufacturers of products in development; dependence on the affect of the
potential development and approval of other new competitive products; dependence
on unexpected adverse side-effects or inadequate therapeutic efficacy of the
Company’s drug candidates that could slow or prevent product approval or market
acceptance (including the risk that current and past results of clinical trials
are not necessarily indicative of future results of clinical trials).
Other
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 Acura’s Form 10-K for the year ended December 31, 2007 and Form 10-Q
for the quarter ended March 31, 2008 which are on file with the U.S. Securities
and Exchange Commission. The Company does not undertake to publicly update
or
revise any of its forward-looking statements even if experience or future
changes show that the indicated results or events will not be
realized.