MARLEY SEAMAN AP Health Writer NEW YORK (AP) — An FDA panel is not recommending approval for an injectable gel designed to reduce knee pain from osteoarthritis, saying clinical studies don’t show the product works. The Orthopedic and Rehabilitation Devices Advisory Committee was considering an application for Durolane, a drug developed by Q-Med AB of Sweden and licensed worldwide to Smith & Nephew of London. The drug contains a natural lubricant called hyaluronic acid, which is present in healthy knee joints. The injection is intended to provide extra cushioning and lubrication for patients with osteoarthritis in the knee. A statistician on the 10-member advisory panel said the companies changed the results of the testing by excluding some patients and combining data from two separate trials, making their product look more effective compared to standard treatment with a saline solution. The exact results of the vote were not disclosed, and the FDA did not identify the statistician who reviewed the report. In notes posted to the FDA’s Web site on Wednesday, the statistician said two clinical trials found that Durolane was not significantly better than an injection of saline at treating osteoarthritis pain. According to the report, the companies then combined results from the two studies, left out about half the patients, and reanalyzed the data, which showed that Durolane was more effective than the saline injection. The results “are neither statistically valid nor acceptable,” the statistician wrote. The panel also asked questions about the use of a different drug as a control in a third trial. That round of testing compared Durolane to the steroid methylprednisolone instead of saline. The FDA does not have to follow the recommendations of its advisory panels, but it often does so. The companies say they will work with the FDA to satisfy its requests. They said Durolane is on the market in 32 countries around the world.
