European Approval Sought for Pennsaid® for Osteoarthritis

Canadian drug maker Dimethaid Research Inc. is seeking approval to market its osteoarthritis drug Pennsaid® in countries that are part of the European Union.

Pennsaid is applied to the skin using a new drug delivery technology in combination with diclofenac sodium, a non-steroidal anti-inflammatory drug (NSAID) that relieves the pain, stiffness and impaired physical function association with osteoarthritis. Topical application of Pennsaid means that the drug doesn't have to be delivered internally, which in the case of NSAIDs often cause side effects such as internal bleeding and ulcers.

"Europe represents a significant opportunity for us as we launch marketing initiatives for Pennsaid worldwide," said Rebecca Keeler, President and CEO of Dimethaid Research. "Osteoarthritis sufferers in these countries deserve an effective treatment without the side effects that often come with currently available oral medication."

While NSAIDs are the most commonly prescribed pain medication in the European Union, a recent report has estimated that the gastrointestinal side effects of oral NSAIDs place a huge financial burden on the European healthcare system. An estimated 103 million people are currently suffering from arthritis in Europe.

Pennsaid is marketed in the United Kingdom and parts of the Caribbean and has received final marketing authorizations from regulatory agencies in the United Kingdom, Luxembourg, Austria and Finland and initial authorization from Italy. Pennsaid regulatory submissions are currently under review in the United States and Canada.

Other sources: Dimethaid Research