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
October
17, 2005
Date
of
Report (Date of earliest event reported)
___________________________________________________________
ACURA
PHARMACEUTICALS, INC.
(Exact
Name of Registrant as Specified in Charter)
___________________________________________________________
State
of New
York
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1-10113
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11-0853640
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(State
of Other Jurisdiction of
Incorporation)
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(Commission
File Number)
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(I.R.S.
Employer Identification
Number)
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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 (17CFR
240.14a-12)
o› Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17CFR240.14d-2(b))
o› Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17CFR
240.13e- 4(c))
On
October 17, 2005, Acura Pharmaceuticals, Inc. (the "Company") issued a press
release announcing the Company’s receipt from the U.S. Food and Drug
Administration (“FDA”) of communications clarifying previous FDA correspondence
relating to the development of Product Candidate #2 announced on October
3,
2005. The FDA’s most recent communication provides assurance that the Company
may promptly resume planned clinical studies of Product Candidate #2 without
conducting additional pre-clinical testing. A copy of the Company’s Press
Release is attached hereto as Exhibit 99.1.
Item
9.01 Financial
Statements and Exhibits.
Exhibit
Number
|
Description |
99.1
|
Press
Release dated October 17, 2005 Announcing Receipt of clarifying
FDA
Communication.
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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.
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ACURA
PHARMACEUTICALS, INC. |
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By: |
/s/ Peter
A. Clemens |
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Peter
A. Clemens |
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Vice
President & Chief Financial Officer |
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Date: October
17, 2005 |
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EXHIBIT
INDEX
Exhibit
Number
|
Description |
99.1
|
Press
Release dated October 17, 2005 Announcing Receipt of clarifying
FDA
Communication.
|