Dimethaid's Pennsaid lotion gets boost from U.S. study
Dimethaid Research Inc (TSX:DMX)
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Wednesday October 13 2004 - News Release
Ms. Jodi Peake reports
U.S. MEDICAL JOURNAL PUBLISHES PENNSAID(R) EFFICACY AND SAFETY STUDY
Dimethaid Research Inc. has highlighted a U.S. study published by Archives of Internal Medicine which provides additional support for the efficacy and safety of Pennsaid anti-arthritic lotion. Pennsaid is currently co-promoted in Canada through a partnership between Dimethaid and Solvay Pharma Inc.
Written by lead investigator Dr. Sanford H. Roth, medical director of Arizona Research and Education, and Dr. J. Zev Shainhouse, Dimethaid's medical director, the Archives article is the third peer-reviewed Pennsaid study to be published since August.
The study, which enrolled 326 patients with knee osteoarthritis, found that Pennsaid improved pain scores by 45.7 per cent, physical function by 36.7 per cent and stiffness by 35.1 per cent -- a statistically significant difference over results from a control group that received the chemical carrier alone, minus the active drug. Two hundred and twenty-eight patients completed the study, and researchers measured the results using the same FDA-mandated standards applied to oral non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 selective inhibitors.
Commenting on the significance of the research, Dr. Roth said: "Systemic NSAID toxicity has been identified as a major problem, especially among the elderly who make up the core OA treatment population. A proven alternative to systemic NSAIDs is urgently required."
Pennsaid relies on a proprietary chemical carrier to deliver a painkiller (diclofenac) through the skin to the disease site. Unlike pills, Dimethaid's technology exposes the bloodstream to minimal amounts of active drug, an approach the company credits for the reduced incidence of serious side effects.
During the 12-week study, patients treated with Pennsaid or control solution showed no significant difference in the incidence of blood pressure, respiration, GI or renal adverse events.
Pennsaid treatment was associated with a higher incidence of localized, minor skin reactions. The authors noted that an ingredient in Dimethaid's chemical carrier has been known to cause dryness and suggested that common skin lubricants should prevent most reactions at the application site.
"Treating osteoarthritis with oral NSAIDs often involves a trade-off between risk and benefit, a point that has certainly come to light with the publicity surrounding COX-2 NSAIDs and cardiovascular morbidity," said Dr. Roth. "With Pennsaid, we did not see the common NSAID-related adverse events, which still require a major warning for ulcer bleeds and deaths, cardiovascular clotting events and kidney failure. This did not occur despite careful monitoring of topical Pennsaid patients."
Initial results from the study were presented at the 2002 European Congress of Rheumatology in Stockholm, Sweden, and subsequently published as an abstract in Annals of the Rheumatic Diseases. The complete article is available on-line at archinte.ama-assn.org. The results also form part of the new drug application originally submitted by Dimethaid to the U.S. Food and Drug Administration.
WARNING: The company relies upon litigation protection for "forward-looking" statements.
© 2004 Canjex Publishing Ltd. |
