Nuvo says analysis of long-term data shows Pennsaid is safe

New York, April 26 - Nuvo Research Inc. said it completed the analysis from its phase 3 long-term open-label safety trial for Pennsaid and found the drug's safety was confirmed.

"These results along with the positive clinical efficacy results we have reported will form a major part of our U.S. NDA re-submission for Pennsaid, which remains on track for mid-2006," said Henrich Guntermann, Nuvo's president and chief executive officer in a news release.

Pennsaid (1.5% w/w diclofenac sodium solution) is a topical non-steroidal anti-inflammatory (Nsaid) used for the treatment of osteoarthritis and is currently approved for sale in Canada and several European countries.

The latest study was of 793 patients with symptoms of osteoarthritis of the knee. Of the total, 448 patients were treated for at least 6 months and 116 patients for at least a year.

Findings confirmed earlier results from three-month trials.

The most prevalent adverse event noted was application site skin irritation in the form of dry skin - as has been observed in previous trials and is noted in both the Canadian and European product labels. As anticipated, with prolonged, continuous use more patients experienced some application site skin reaction. The key observation was that long-term use did not cause any new, unexpected adverse event, Nuvo said.

Nuvo is a Mississauga, Ont. pharmaceutical company.

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