Specialty pharmaceutical developer, Dimethaid Research Inc., has received final Health Canada approval for Pennsaid®, a topically applied, nonsteroidal anti-inflammatory drug (NSAID). The approval gives physicians a new option for treating the pain, stiffness and physical impairment that result from osteoarthritis (OA) of the knee.
“This is an historic achievement, the first drug of its kind in Canada,” says Rebecca Keeler, Dimethaid’s president and CEO. “Pennsaid is the country’s one and only topical, prescription OA therapy.
The new drug will be an alternative to oral NSAIDs, such as ibuprofen and naproxen, which have been linked to serious side effects including gastrointestinal bleeding, kidney and liver disease.
“We expect Pennsaid will be widely prescribed because it fills an obvious gap,” says Dimethaid’s medical director, Dr. Zev Shainhouse. “There are many patients who don’t need, don’t want, or can’t take oral NSAIDs.”
A 1998 paper published in the Journal of Rheumatology reports that up to 30 percent of patients taking traditional NSAIDs develop persistent GI symptoms, and more than 10 percent discontinue treatment. The Arthritis Society also estimates that up to 1,900 Canadians die every year from complications related to oral NSAID use.
Pennsaid has been designed to decrease the likelihood of serious side effects. The treatment combines a chemical carrier with diclofenac sodium, a proven anti-arthritic, and delivers active drug through the skin directly to the site of disease. This more targeted approach introduces only negligible amounts of NSAID into the bloodstream — up to 150 times lower than levels reported for comparable oral medication. Clinical trial data has repeatedly demonstrated the product’s ability to relieve symptoms without provoking serious GI or other systemic side effects. Following Pennsaid application, the most frequently reported adverse event has been a localized patch of dry or irritated skin.