Pennsaid(R) Phase 3 study results to be published in leading international PAIN journal

    MISSISSAUGA, ON, April 23 /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
demonstrating that the Company's lead product, Pennsaid, a topical
non-steroidal anti-inflammatory drug (NSAID), is an efficacious treatment for
the symptoms of osteoarthritis of the knee will be published in the June 2009
edition of PAIN.
    PAIN is the world's leading publication on pain research and treatments
and the official journal of the International Association for the Study of
Pain (IASP(R)). The IASP, founded in 1973, is the leading professional forum
for science, practice, and education in the field of pain and has more than
6,500 members in 118 countries who are professionals involved in the research,
diagnosis and treatment of pain.
    The scientific article details Nuvo's previously announced study results,
which demonstrated that Pennsaid is efficacious for the relief of symptoms in
patients with knee osteoarthritis. In addition, the study demonstrated that
Pennsaid is as effective as oral diclofenac at relieving knee osteoarthritis
symptoms but with less NSAID-related systemic toxicity. The article, titled,
"Efficacy and safety of topical diclofenac containing dimethyl sulfoxide
(DMSO) compared with those of topical placebo, DMSO vehicle and oral
diclofenac for knee osteoarthritis", was written by Dr. Lee Simon as lead
author, and Dr. Lisa Grierson, Zahid Naseer, Dr. Arthur A.M. Bookman, M.D.,
and Dr. J. Zev Shainhouse as co-authors. It is currently available on the PAIN
    "The publication of this article in the premier international pain
journal further confirms Pennsaid's unique and compelling efficacy and safety
profile among all other topical NSAIDs," said Dr. Brad Galer, Vice President
and General Manager of Nuvo's Pain Group. "This published data provides
further support to our conclusion that Pennsaid, when approved by the U.S.
Food and Drug Administration (FDA), will be the best-in-class product
available in the United States."
    Nuvo resubmitted its application for Pennsaid approval to the FDA in
February 2009. The FDA has indicated that it intends to advise Nuvo of its
decision regarding the approval of Pennsaid by August 5, 2009 (the "PDUFA
Date") under the Prescription Drug User Fee Act.
    The subject of the PAIN article is Nuvo's Phase 3 trial, Study 112, which
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 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) plus oral placebo, 4) topical placebo
plus oral diclofenac and 5) Pennsaid plus oral diclofenac.
    Pennsaid (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 (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
(arm 1) and oral diclofenac (arm 4) for all three efficacy 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 if combined with an oral NSAID.
This combination showed no increased incidence of the usual systemic side
effects, just the expected additive profiles of Pennsaid alone plus oral
diclofenac alone.
    Dry skin was the most common adverse event with Pennsaid use. Fewer
digestive system adverse events and laboratory abnormalities (decreased
hemoglobin and increased AST, ALT and creatinine) were observed with Pennsaid
as compared to 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 drug (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
    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

    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 Company
considers 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 future events, many of which are beyond the control of
the Company, 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 report, as well as in the Company's Annual Information
Form for the year ended December 31, 2008. The Company disclaims any intention
or obligation to update or revise any forward-looking statements whether a
result of new information or future events, except as required by law. For
additional information on risks and uncertainties relating to these
forward-looking statements, investors should consult the Company's ongoing
quarterly filings, annual report and Annual Information Form and other filings
found on SEDAR at

For further information:

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

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