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Yesterday, Q-Med and its UK partner Smith & Nephew plc (LON: SN) discussed the trial results for Durolane, a single-dose product for the treatment of osteoarthritis pain in the knee, with the Orthopaedic and Rehabilitation Devices Advisory Committee of the US Food and Drug Administration (FDA).
Q-Med and Smith & Nephew will work together to provide the necessary information.
On Monday, the FDA presented materials saying that the clinical studies did not show any statistical difference between Durolane and a saline-control product.
However, in the published document, the FDA said that Durolane is generally safe, which is the most important factor in this case as the product is not a medicine, two unnamed analysts told Swedish news wire Nyhetsbyran SIX on this occasion.
Smith & Nephew holds the exclusive global marketing rights to Durolane, which is already sold in 20 countries, including Canada.
Comments on this story may be sent to nbr.feedback@nordicbusinessreport.com
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