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Nuvo Research Presents Positive Phase III Study Results For Pennsaid At Leading Rheumatology Conference
Nuvo Research Inc.
(TSX: NRI), a Canadian drug development company focused on the research and
development of drug products delivered to and through the skin using its
topical and transdermal drug delivery technologies, announced that
study results showing that Pennsaid, Nuvo's topical diclofenac solution, is
an effective treatment option for the symptoms of osteoarthritis of the
knee, with an improved safety profile compared to oral diclofenac, were
detailed in a poster presentation at the 2008 American College of
Rheumatology Scientific Meeting in San Francisco.
The lead author of the presentation was Dr. Lee Simon, Associate
Clinical Professor of Medicine, Harvard Medical School. This was the first
presentation to a medical and scientific audience of the Phase III clinical
study results, which were originally announced by the Company upon study
completion in January 2006.
"Presenting at a prestigious event such as the American College of
Rheumatology Scientific Meeting provides Nuvo with a forum to share our
compelling Pennsaid clinical data with medical and scientific leaders,"
said Dr. Brad Galer, Vice President and General Manager of Nuvo's Pain
Group. "As we move closer to Pennsaid's approval by the U.S. FDA, it is
important that the professional rheumatology community be aware of what we
believe is the strongest clinical efficacy and safety evidence of any
topical NSAID formulation for the treatment of osteoarthritis. We believe
that this data supports the conclusion that Pennsaid, once approved, will
be the best-in-class product available in the U.S."
"These results confirm and extend previous studies and show that this
novel topical diclofenac solution is efficacious for the relief of symptoms
in patients with symptomatic knee osteoarthritis," said Dr. Marc C.
Hochberg, Head, Division of Rheumatology & Clinical Immunology at the
University of Maryland School of Medicine. "Furthermore, it had similar
efficacy to orally administered diclofenac with fewer gastrointestinal,
hepatic and renal adverse events. Topical NSAIDs should be considered in
the management of patients with symptomatic osteoarthritis involving joints
accessible to these agents."
Nuvo's Phase III trial, Study 112, enrolled 775 patients in the U.S.
and Canada with symptoms of primary osteoarthritis of the knee. Patients in
this five-arm, double-blind, 12-week trial applied a topical solution and
took an oral pill. The five arms were: 1) Pennsaid(R) plus oral placebo, 2)
topical placebo containing a small amount of DMSO for blinding purposes
(DMSO facilitates delivery of diclofenac to the knee) plus oral placebo, 3)
topical vehicle-control (containing the same concentration of DMSO as in
Pennsaid(R)) plus oral placebo, 4) topical placebo plus oral diclofenac and
5) Pennsaid(R) plus oral diclofenac.
Pennsaid(R) (arm 1) was superior to placebo (arm 2) with statistically
significant improvement in all three primary clinical endpoints required by
the FDA: pain relief (p=0.019), improvement in physical function (p=0.046)
and improved patient overall health assessment (POHA) (p less than 0.0001).
Additional results from the trial show that Pennsaid(R) (arm 1) was
superior to vehicle control (arm 3) (pain, p=0.009; physical function,
p=0.026; POHA, p=0.016). There was no difference between vehicle control
(arm 3) and placebo (arm 2) indicating that DMSO alone is ineffective
against the symptoms of knee osteoarthritis (p greater than 0.05). There
was no difference between Pennsaid(R) (arm 1) and oral diclofenac (arm 4)
for all three endpoints (p greater than 0.05). Arm 5 was included in the
trial at the FDA's request to review the side effect profile of Pennsaid(R)
if combined with an oral NSAID. This combination showed no increased
incidence of the usual side effects, just the expected additive profiles of
Pennsaid(R) alone plus oral diclofenac alone.
Further data published today in the poster presentation showed that dry
skin was the most common adverse event with Pennsaid use. Fewer digestive
system adverse events and laboratory abnormalities (hemoglobin, AST, ALT,
creatinine) were observed with Pennsaid than oral diclofenac.
About Nuvo Research Inc.
Nuvo is focused on the research and development of drug products
delivered to and through the skin using its topical and transdermal drug
delivery technologies. Nuvo's lead product is Pennsaid(R), a topical
non-steroidal anti-inflammatory (NSAID) used for the treatment of
osteoarthritis. Nuvo intends to leverage its skin-penetrating technologies
to create a portfolio of topical and transdermal products targeting a
variety of indications.
Nuvo Research Inc. is a publicly traded, Canadian pharmaceutical
company headquartered in Mississauga, Ontario, with manufacturing
facilities in Varennes, Quebec and Wanzleben, Germany and a research and
development Center in San Diego California. For more information, please
visit http://www.nuvoresearch.com.
These forward-looking statements, by their nature, necessarily involve
risks and uncertainties that could cause actual results to differ
materially from those contemplated by the forward-looking statements. The
Companies consider the assumptions on which these forward-looking
statements are based to be reasonable at the time they were prepared, but
caution that these assumptions regarding the future events, many of which
are beyond the control of the Companies and their subsidiaries, may
ultimately prove to be incorrect. Factors and risks, which could cause
actual results to differ materially from current expectations, are
discussed in the annual reports, as well as in the Companies' Annual
Information Forms for the year ended December 31, 2007. The Companies
disclaim any intention or obligation to update or revise any
forward-looking statements whether a result of new information, future
events, or except as required by law. For additional information on risks
and uncertainties relating to these forward-looking statements, investors
should consult the Companies' ongoing quarterly filings, annual reports and
Annual Information Forms and other filings found on SEDAR at http://www.sedar.com.
Nuvo Research Inc
http://www.nuvoresearch.com
Nuvo Cercetare Prezintã pozitive de fazã III de studiu Rezultate pentru Pennsaid La Leading Rheumatology de conferinte - Nuvo Research Presents Positive Phase III Study Results For Pennsaid At Leading Rheumatology Conference - articole medicale engleza - startsanatate