Smith & Nephew Proceeds Single Injection PMA To Next Stage

For the use of DUROLANE in the treatment of knee pain caused by osteoarthritis

Smith & Nephew Biologics & Spine is proceeding to the next stage in the approval process for the US launch of DUROLANE Single Injection, Stabilized Hyaluronic Acid.

ADVERTISEMENT Representatives from the product developer, Q-Med of Sweden, and their global commercial partner, Smith & Nephew met with the FDA’s Orthopaedic and Rehabilitation Devices Advisory Committee to discuss clinical evidence for the use of DUROLANE in the treatment of knee pain caused by osteoarthritis (OA).

The FDA Advisory Committee did not recommend DUROLANE for immediate approval, requesting further information as part of the Premarket Approval (PMA) process for the product. Smith & Nephew plans to work with Q-Med and the FDA to provide the data required.

Mark Augusti, president of Smith & Nephew Biologics & Spine, said: We are committed to expanding our range of HA therapies in the United States. Use of our multi-injection SUPARTZ Joint Fluid Therapy as a treatment for knee OA continues to increase and we are exploring its potential for other indications.

Smith & Nephew and Q-Med have an exclusive partnership for the global development and commercialization of DUROLANE. It is already marketed in 32 countries, including Canada, and has been used to treat the symptoms of OA in more than 350,000 patients worldwide.