Nuvo to refile Pennsaid NDA after completion of successful phase 3 trial

By Angela McDaniels

Seattle, Dec. 22 - Nuvo Research Inc. said a preliminary analysis of a phase 3 clinical trial has confirmed the effectiveness of Pennsaid in the relief of the symptoms of osteoarthritis of the knee.

The 12-week, multi-arm trial was designed to answer deficiencies noted by the Food and Drug Administration in a non-approvable letter issued by the agency in August 2002.

The trial met the primary endpoints of pain, physical function and patient overall health assessment, thus demonstrating the superiority of Pennsaid over a placebo. The trial also demonstrated Pennsaid's efficacy compared to an oral anti-inflammatory drug.

Nuvo said a full analysis of the trial will be announced in January.

"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," president and chief executive officer Henrich Guntermann said in a company news release.

The company said it anticipates filing an amended New Drug Application for Pennsaid in mid 2006.

Pennsaid is a topical, non-steroidal anti-inflammatory used for the treatment of osteoarthritis. It is approved for sale in Canada and several European countries.

Based in Markham, Ont., Nuvo develops therapeutics that are delivered transdermally using the company's skin-penetrating technologies.

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