FDA Panel Votes Against Q-Med's Knee Injection Product

A panel of medical experts recommended Wednesday that federal regulators not approve Q-Med AB's (QMED.SK) knee-injection product, Durolane.

The panel voted 6-to-1 to recommend against approval for the product, saying studies submitted by the company didn't show it was effective enough when compared to a placebo. The U.S. Food and Drug Administration doesn't have to follow its panel's advice, but generally does.

Durolane is already sold in Europe. It's a gel that's injected into the knee to help increase joint lubrication and cushioning and relieve pain. It's used to relieve pain in patients with oestoarthritis of the knee who haven't responded to other pain treatments.

If approved, the product will be marketed by Smith & Nephew Plc (SNN).

Mark Melkerson, director of the FDA's division of orthopedic, surgical and restorative devices, said the panel "couldn't get past the fact" that two studies submitted by the company showed it wasn't more effective when compared to a placebo.

Melkerson said the panel was also concerned that a third study showed the product was only marginally better than a competitor's product.

-By Jared A. Favole, Dow Jones Newswires; 202.862.9207; [e-mail]