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 9, 2000
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(Date of Report)
ENTROPIN, INC.
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(Exact Name of Registrant as specified in its charter)
COLORADO 33-23693 84-1090424
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
45926 OASIS STREET, INDIO, CALIFORNIA 92201
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(Address of principal executive offices including zip code)
(760) 775-8333
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(Registrant's telephone number including area code)
N/A
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(Former name or former address, if changed since last report)
ITEM 5. OTHER EVENTS.
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Entropin, Inc. ("Entropin") has received the results of the Phase III
A clinical trials required by the U.S. Food and Drug Administration. On
October 2, 2000, the Registrant issued the following press release:
NEWS RELEASE
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ESTEROM(R) SOLUTION DEMONSTRATES ENCOURAGING RESULTS IN
PRELIMINARY ANALYSIS OF PHASE IIIA STUDY
INDIO, CA (OCTOBER 2, 2000): Entropin, Inc. (Nasdaq: ETOP; ETOPW) today
announced encouraging results from a preliminary analysis of a double-blinded,
placebo-controlled Phase IIIA study of its topical investigational
treatment for impaired range of motion, called Esterom(R) solution. Data
from the study showed no significant adverse events. Minor treatment-
emergent side-effects (headache, body pain and skin rash) were few and
equally associated with the placebo and treatment groups. Results of the
study, which investigated 5% and 10% concentrations of Esterom(R) versus
placebo in 362 patients with impaired shoulder function, showed a positive
dose response in treated patients. Data from the study also showed a trend
toward efficacy in the study's primary endpoint at the 10% dose, although
statistical significance was not achieved (p=0.14). The objective in the
study was to achieve statistical significance at the p=0.05 level. The
primary endpoint of the study was improvement in function as evaluated by
a patient self-administered questionnaire for Assessment of Symptoms and
Function of the Shoulder (QASFS). Treatment by Center interaction, which
is defined as the differences in treatment and data collection between
sites, was statistically significant (p=0.04) suggesting that failure to
achieve significance at the desired level of statistical significance may
be due to deficiencies in the protocol design and/or investigator training.
"We are encouraged by the preliminary analysis from this study, which was
intended to provide further information for refining the design of our
upcoming Phase IIIB trial of Esterom(R) as well as to confirm the safety of
this treatment," said Thomas G. Tachovsky, Ph.D., president and chief
executive officer of Entropin, Inc. "Based on these initial results, we
remain on track to begin our next pivotal study in Q1 2001, which we expect
will support the filing of a New Drug Application (NDA).
He continued, "This was a complex protocol, which investigated the use of
multiple doses of Esterom(R) in a diverse patient population where multiple
factors could effect treatment results. Over the coming weeks, we will be
conducting detailed analyses to examine secondary endpoints of the study
and to better understand the data from this trial, with the aim of using
that knowledge to further our clinical investigations of Esterom(R). We
plan to announce the results from the detailed analysis of the Phase IIIA
study later this fall."
Dr. Tachovsky noted, "In preclinical and controlled Phase I and II human
clinical studies,
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Esterom(R) has demonstrated the ability to rapidly and significantly
restore range of motion, without any observable toxicity, in multiple
clinical indications."
Esterom(R) solution is a topical medicinal preparation that is currently
under investigation as a treatment for impaired range of motion associated
with acute painful shoulder and acute lower back sprain. The exact
mechanism of action for Esterom(R) is as yet unknown - it is not an anti-
inflammatory drug nor is it an anesthetic.
Entropin, Inc. is a pharmaceutical research and development company,
initially focused on the development of a novel topical therapeutic called
Esterom(R) solution. Entropin is currently conducting Phase III trials of
Esterom(R) in patients with acute impaired shoulder function and plans to
file a New Drug Application with the U.S. Food and Drug Administration
(FDA) for that indication. For further information, please contact Dr.
Higgins Bailey, chairman, or Patricia Kriss, chief financial officer at
(760) 775-8333 or visit our website at www.entropin.com.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF
1995: This release includes forward-looking statements which reflect
Entropin's current views with respect to future events and financial
performance. The words "believe," "expect," "anticipate," and similar
expressions identify forward-looking statements. Investors should not
rely on forward-looking statements because they are subject to a variety of
risks, uncertainties, and other factors that could cause actual results to
differ materially from those expressed in any such forward-looking
statements. These factors include, but are not limited to: (1) the ability
to successfully complete development and commercialization of products,
including the cost, scope and results of preclinical and clinical testing;
(2) the ability to successfully complete product research and further
development, including animal, pre-clinical and clinical studies; (3) the
time, cost and uncertainty of obtaining regulatory approvals; (4) the
ability to obtain substantial additional funding; (5) the ability to
develop and commercialize products before competitors; and (6) other
factors detailed from time to time in filings with the Securities and
Exchange Commission.
SIGNATURES
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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.
Date: October 6, 2000 ENTROPIN, INC.
By /s/ Thomas G. Tachovsky
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Thomas G. Tachovsky
President and Chief Executive Officer
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