Nuvo Research presents positive Phase III study results for Pennsaid at leading rheumatology conference
Monday October 27, 5:00 pm ET
MISSISSAUGA, ON, Oct. 27 /CNW/ - Nuvo Research Inc. (TSX: NRI - News), 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.
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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.
