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
17,
2008
Date
of
Report (Date of earliest event reported)
ACURA
PHARMACEUTICALS, INC.
(Exact
Name of Registrant as Specified in Charter)
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1-10113
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11-0853640
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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 (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
17, 2008 we announced positive
top-line results from a pivotal Phase III study, AP-ADF-105 (“Study 105”). Both
strengths of Acurox™ Tablets met the primary pain relief endpoint compared to
placebo (p=.0001, and p<.0001). The most prevalent reported adverse events in
patients receiving Acurox™ Tablets were nausea, vomiting, dizziness, pruritis
and flushing. Study 105 was conducted under the U.S. Food and Drug
Administration (“FDA”) Special Protocol Assessment (“SPA”) provision. We have
licensed the rights to Acurox™ Tablets to King
Pharmaceuticals Research and Development, Inc. (“King”), a wholly-owned
subsidiary of King Pharmaceuticals, Inc., pursuant to a License, Development
and
Commercialization Agreement between King and us, dated as of October 30, 2007.
We
expect
to submit a New Drug Application (“NDA”) for Acurox™ Tablets to the FDA by the
end of this year with a targeted indication for the relief of moderate to severe
pain where the use of an immediate release, orally administered, opioid
analgesic tablet is appropriate.
Study
105
was a pivotal Phase III, randomized, double-blind, placebo-controlled clinical
trial evaluating the efficacy and safety of Acurox™ Tablets for relief of
moderate to severe pain following bunionectomy surgery. A total of 405 patients
were randomized to one of three treatment arms of approximately 135 patients
per
arm. One treatment arm received a dose of two Acurox™ (oxycodone HCl/niacin)
Tablets 5/30mg, a second treatment arm received a dose of two Acurox™ Tablets
7.5/30mg, and the third treatment arm received a dose of two placebo tablets.
Study drugs were administered every 6 hours. The primary endpoint was the sum
of
the difference in pain intensity, measured on a 100mm visual analog scale (VAS),
compared to baseline over a 48 hour period (“SPID48”).
Prior
to initiating Study 105, the study design, endpoints and statistical analysis
plan were submitted to and agreed by the FDA under a Special Protocol Assessment
and the study was conducted accordingly. Both Acurox™ Tablet strengths met the
primary endpoint: p=.0001 for Acurox™ Tablets 5mg/30mg and p<.0001 for
Acurox™ Tablets 7.5mg/30mg. The most prevalent reported adverse events in
patients receiving Acurox™ Tablets were nausea, vomiting, dizziness, pruritis
and flushing. Most adverse events were reported as mild or moderate and there
were no serious adverse events. Six patients (2.2%) receiving Acurox™ Tablets
withdrew from the study due to treatment-emergent adverse events compared with
no withdrawals for the placebo group.
A
copy of
the press release issued by us is being furnished as Exhibit 99.1.
Item
9.01 Financial
Statements and Exhibits
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Exhibit Number
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Description
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99.1
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Joint
Press Release of the Registrant and King Pharmaceuticals, Inc. dated
June
17, 2008.
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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:
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/s/
Peter Clemens
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Peter
A. Clemens
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Senior
Vice President & Chief Financial
Officer
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Date: June
17,
2008
EXHIBIT
INDEX
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Exhibit Number
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Description
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99.1
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Joint
Press Release of the Registrant and King Pharmaceuticals, Inc. dated
June
17, 2008.
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