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Q-Med submits DUROLANE regulatory file to the US FDA |
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20 Mar 2006 |
UPPSALA, Sweden | Mar 20, 2006 | Q-Med AB today announced that it submits a pre-market approval (PMA) application to the US FDA for DUROLANE, intended for the treatment of pain caused by osteoarthritis (OA) of the knee. DUROLANE is the first single-injection viscosupplementation/joint fluid therapy product. The US viscosupplementation market for OA is expected to reach USD 420 million in 2006 (Source Millennium Research Group 2005).
"A single-injection course of treatment like DUROLANE, with comparable efficacy to our competitors' products that must be injected 3 to 5 times per course of treatment, will certainly be beneficial to patients, physicians and to society. We also know that patients appreciate the fact that we have a non-animal based product", says Bengt Ågerup, Ph.D. and CEO of Q-Med AB.
DUROLANE is a viscoelastic gel of highly purified non-animal hyaluronic acid based on Q-Med's proprietary NASHA technology. The gel is stabilized to achieve a prolonged intra-articular residence time. DUROLANE has been commercially available in the EU and Canada since 2002 and is indicated for the treatment of OA of the knee and hip. Thousands of patients have already been treated with DUROLANE.
Clinical studies performed in North America and the EU including 564 patients show that DUROLANE provides superior pain relief compared to placebo at 6 weeks post-injection. For patients followed for up to 6 months DUROLANE treatment resulted in persistent pain relief. No treatment-related serious adverse event or allergic reactions to DUROLANE have been reported.
SOURCE: Q-Med |
