Nuvo study says Pennsaid good for arthritic knees
Nuvo Research Inc (TSX:NRI)
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Thursday December 22 2005 - News Release
Nuvo Research Inc. has released efficacy results from its preliminary analysis of the phase 3 efficacy/safety trial for Pennsaid, designated "Study 112." The results have confirmed the effectiveness of Pennsaid in the relief of the symptoms of osteoarthritis of the knee. Pennsaid is a topical non-steroidal anti-inflammatory (NSAID) used for the treatment of osteoarthritis approved for sale in Canada and several European countries.
The 12-week phase 3, multiarm trial was designed with the input of the United States Food and Drug Administration to answer deficiencies noted in a non-approvable letter issued by the FDA in August, 2002. The trial met all its primary end points being pain, physical function and patient overall health assessment, thus demonstrating the superiority of Pennsaid over a placebo. The trial also demonstrated comparable efficacy of Pennsaid to an oral NSAID. Full analysis of the trial has not yet been completed and will be announced in January, 2006.
Dr. Henrich Guntermann, Nuvo's president and chief executive officer, said: "We are delighted to see that the positive efficacy results of this trial for Pennsaid are in line with those previously reported and published from our earlier phase 3 trials. We look forward to the final data from our phase 3 long-term, open-label safety trial (designated "Study 112E"), which we expect to be available in February, 2006. Armed with the results of these studies, we anticipate filing an amended new drug application for Pennsaid with the FDA in mid-2006. The Nuvo management team will continue to work with our recently announced group of accomplished FDA advisers to prepare the submission."
© 2005 Canjex Publishing Ltd. |
