The objective of the study is to confirm naproxcinod's efficacy and provide additional blood pressure data, a key factor to differentiate naproxcinod from existing treatments. The company also is aiming to make NicOx the drug-of-choice for treating the signs and symptoms of osteoarthritis. Efficacy results are expected in mid-2008.
“The initiation of this second pivotal phase III trial is in line with our development plan for naproxcinod, which foresees the filing of a New Drug Application in the US during the first quarter of 2009,” said Michele Garufi, chairman and CEO of NicOx.
The start of this trial follows the successful results obtained for naproxcinod in previous phase II and phase III trials, which showed superior efficacy to placebo and no detrimental effect on blood pressure, when compared to existing non-steroidal anti-inflammatory drugs (NSAIDs). It has been suggested that NSAIDs carry cardiovascular side effects.
NicOx plans to initiate a third phase III trial in the first half of 2007, which will assess naproxcinod's efficacy and safety in patients with osteoarthritis of the hip.