SCOLR Pharma Announces Completion of Patient Enrollment and Dosing for Pivotal Clinical Trial Evaluating Extended Release Ibupro
09 10월 2008 - 10:00PM
PR Newswire (US)
Top Line Clinical Results Expected in November 2008 BOTHELL, Wash.,
Oct. 9 /PRNewswire-FirstCall/ -- SCOLR Pharma, Inc. (AMEX: DDD)
announced today the completion of patient enrollment and dosing for
the third of its three pivotal trials to evaluate the safety and
efficacy of its formulation of 12-hour extended-release (ER)
ibuprofen for the over-the-counter (OTC) market. The Company
expects to report top-line results from this pivotal trial in
November 2008. Ibuprofen is an analgesic that is sold in
immediate-dose products as Advil(R) and Motrin(R), among others, as
well as generically. The Company enrolled and treated approximately
240 patients at a single center in the United States. The
randomized, placebo-controlled, double-blind, parallel group study
was designed to evaluate the efficacy and safety of multiple doses
of ibuprofen 600mg ER in dental pain following molar extraction. It
is anticipated that the data from this trial will be used to
support a submission to the U.S. Food and Drug Administration (FDA)
for product approval in the United States. If approved, the Company
believes its ibuprofen product would be the first and only OTC
12-hour, extended-release ibuprofen product on the market in the
United States. Additional information about the clinical trial can
be found at http://www.clinicaltrials.gov/. As previously reported,
the Company will also be required to complete a label comprehension
and consumer use study for product approval prior to submission.
Daniel O. Wilds, the Company's Chief Executive Officer, commented,
"We are very pleased with the efficiency in which over 300
potential subjects were recruited and screened to enable the
successful and timely dosing of our targeted study population. The
attainment of this clinical study milestone is an important measure
of our success in advancing this exciting project and we look
forward to announcing study results later this year." Ibuprofen is
an analgesic typically used for the treatment of pain, fever and
inflammation. Total global OTC sales of the analgesic market in
which the 12-hour ibuprofen product will compete are estimated at
more than $8 billion, according to IMS Review Plus data. The
Company estimates the annual U.S. sales of immediate-release OTC
ibuprofen products exceeds $1 billion. About SCOLR Pharma: Based in
Bothell, Washington, SCOLR Pharma, Inc. is a specialty
pharmaceutical company. SCOLR Pharma's corporate objective is to
combine its formulation expertise and its patented CDT platform to
develop novel pharmaceutical, over-the-counter (OTC), and
nutritional products. Our CDT drug delivery platform is based on
multiple issued and pending patents and other intellectual property
for the programmed release or enhanced performance of active
pharmaceutical ingredients and nutritional products. For more
information on SCOLR Pharma, please call 425.373.0171 or visit
http://www.scolr.com/. This press release contains forward-looking
statements (statements which are not historical facts) within the
meaning of the Private Securities Litigation Reform Act of 1995,
including without limitation statements related to the timing and
success of clinical trials and regulatory applications. These
forward-looking statements involve risks and uncertainties,
including activities, events or developments that we expect,
believe or anticipate will or may occur in the future. A number of
factors could cause actual results to differ from those indicated
in the forward-looking statements, including our ability to
successfully develop new formulations and complete research and
development, including pre-clinical and clinical studies, our
ability to raise additional funds, the continuation of arrangements
with our product development partners and customers, competition,
government regulation and approvals, and general economic
conditions. For example, if our clinical trials are not successful
or take longer to complete than we expect, we may not be able to
develop and commercialize our products and we may not obtain
regulatory approval for our products, which would materially impair
our ability to generate revenue. Additional assumptions, risks and
uncertainties are described in detail in our registration
statements, reports and other filings with the Securities and
Exchange Commission. Such filings are available on our website or
at http://www.sec.gov/. You are cautioned that such statements are
not guarantees of future performance and that actual results or
developments may differ materially from those set forth in the
forward-looking statements. We undertake no obligation to publicly
update or revise forward-looking statements to reflect subsequent
events or circumstances. Contacts: Investor Relations: Cameron
Associates Kevin McGrath 212.245.4577 DATASOURCE: SCOLR Pharma,
Inc. CONTACT: Kevin McGrath of Cameron Associates, +1-212-245-4577,
, for SCOLR Pharma, Inc. Web Site: http://www.scolr.com/
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