Dimethaid Research Inc announced that results of a second large, multi-center Phase III clinical study of Pennsaid (diclofenac) Topical Solution presented at the 18th Annual General Meeting of the British Society for Rheumatology (BSR), held inconjunction with the Scandinavian Society for Rheumatology in Edinburgh, Scotland.
This study added to the data available from previous studies, by including a larger number of patients, a longer time period and expanded primary measures of osteoarthritis to show that Pennsaid is effective in the site-specific treatment of the symptoms of primary osteoarthritis of the knee. This study further demonstrated the ability of Pennsaid to improve physical function and provide significant pain relief, without the potential for negative, systemic side effects commonly associated with oral non-steroidal anti-inflammatory medications (NSAIDs).
Pennsaid is the first product developed by Dimethaid Research to use its unique carrier technology, a proprietary transdermal delivery system that facilitates the site-specific delivery of drugs with minimal systemic absorption and only minor local irritation.
The double blind, placebo-controlled trial of Pennsaid was conducted with patients suffering moderate to extreme pain in their osteoarthritic knee. The primary outcome measures were the pain and physical function subscales of the WOMAC OA Index as well as a patient global assessment. The WOMAC OA Index subscale of stiffness was used as a secondary outcome measure. The results showed statistically significant (p less than 0.05) improvement in all primary and secondary outcome measures for Pennsaid versus control (the carrier without diclofenac).
"The results of this study highlight our confidence that Pennsaid can provide safe, effective relief of pain symptoms and improve the quality of life for patients suffering from osteoarthritis of the knee and is a viable alternative to oral medications," said Dr. J. Zev Shainhouse, Medical Director of Dimethaid Research. "Patients with mild to extreme pain from osteoarthritis now have the option of a topical treatment, without the risk of any serious side effects."