Covidien introduces PENNSAID to the U.S. market

Covidien (NYSE: COV), a leading global provider of healthcare products, has introduced PENNSAID^® (diclofenac sodium topical solution) 1.5% w/w to the U.S. market. PENNSAID is the only FDA-approved topical non-steroidal anti-inflammatory drug (NSAID) in a vehicle solution containing dimethyl sulfoxide (DMSO), a known penetrating agent. It is indicated for treatment of the signs and symptoms of osteoarthritis of the knee(s).

“Though osteoarthritis is not preventable, many people are able to manage it and maintain an active lifestyle with a well designed treatment program, including medications, exercise, and physical therapy when needed.”

PENNSAID offers patients suffering from osteoarthritis of the knee an effective option for reducing pain and improving physical function.

"We believe PENNSAID will become an important treatment for physicians caring for patients with osteoarthritis of the knee," said Timothy R. Wright, President, Pharmaceuticals, Covidien. "The product's unique formulation with DMSO and its proven clinical effectiveness make it a convenient and innovative treatment for patients who are seeking effective pain relief and improved physical function in their daily lives."

A growing number of guidelines and review committees suggest that the use of topical NSAIDs in the treatment of knee osteoarthritis offers potential significant gastrointestinal safety benefits for certain patients. Localized treatment may provide improved safety and tolerability benefits.

In Phase III clinical trials, PENNSAID demonstrated statistically significant differences in all three primary efficacy endpoints: pain and physical function (as measured by the Western Ontario and McMaster Universities LK3.1 OA Index, or WOMAC subscale), and patient overall health assessment (POHA) / patient global assessment (PGA).

"Ten million Americans suffer from osteoarthritis of the knee, illustrating the clear need for additional treatment alternatives," said Charles Argoff, M.D., Professor of Neurology at Albany Medical College and Director of the Comprehensive Pain Program of Albany Medical Center. "Though osteoarthritis is not preventable, many people are able to manage it and maintain an active lifestyle with a well designed treatment program, including medications, exercise, and physical therapy when needed."

According to the Arthritis Foundation, moderate exercise provides multiple benefits for people with osteoarthritis - reducing joint pain and stiffness, building strong muscle around the joints and increasing flexibility and endurance for osteoarthritic patients. Education around appropriate knee osteoarthritis treatment is especially timely, as May is National Arthritis Awareness Month.

Knee osteoarthritis is one of five leading causes of disability among adults and is a chronic condition characterized by the breakdown of the joint's cartilage. Cartilage cushions the ends of the bones and allows easy movement of joints. The breakdown of this cartilage causes the bones to rub against each other, resulting in stiffness, pain and loss of movement in the joint.

Symptoms of osteoarthritis include joint pain or stiffness following periods of either inactivity or excessive use, a grating or catching sensation during joint movement and bone spurs (small growth of new bone) in the affected joints.

Last November, Covidien with Nuvo Research announced the U.S. Food and Drug Administration (FDA) had approved the New Drug Application for PENNSAID.