Nuvo Research presents positive Phase III study results for Pennsaid at leading rheumatology conference



    MISSISSAUGA, ON, Oct. 27 /CNW/ - 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, today 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, Québec and Wanzleben, Germany and a research and development Center
in San Diego California. For more information, please visit
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 www.sedar.com.

    %SEDAR: 00002418E




For further information:

For further information: about Nuvo, please contact Investor Relations,
Adam Peeler, Equicom Group Inc., Tel: (416) 815-0700 x225, email:
apeeler@equicomgroup.com

Organization Profile

Nuvo Research Inc.

More on this organization


Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890