NicOx sees naproxcinod FDA new application mid-2009
PARIS (Reuters) - French biotechnology group NicOx <NCOX.PA> said on Friday it expected to file a New Drug Application (NDA) with the U.S. Food and Drug Administration in mid-2009 for its osteoarthritis treatment naproxcinod.
NicOx added in a statement it had successfully completed the enrollment of 1020 patients in the 302 pivotal phase 3 study for naproxcinod, in-line with projections.
The 302 study is designed to assess the treatment's efficiency for treating osteoarthritis and provide additional blood pressure data, which is a key factor for differentiating naproxcinod from existing anti-inflammatory treatments.
Results from the study are expected in the third quarter of 2008, it said.
The third and final study (303) is a 13-week trial with patients afflicted with osteoarthritis of the hip. Patient enrollment should be completed in the second quarter of 2008 and results are expected by the end of 2008.
(Reporting by Dominique Vidalon)