NUVO TO BEGIN NEW STUDIES TO SUPPORT PENNSAID APPLICATION

Nuvo Research announced that, based on discussions with the FDA regarding matters raised in its December 2006 approvable letter for Pennsaid, the company plans to begin new studies to support a response to the FDA in the fourth quarter of 2007.

In the approvable letter, the FDA confirmed that Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID) for the treatment of osteoarthritis, could be approved once certain conditions were satisfied. None of the conditions relate to clinical efficacy or safety of Pennsaid, the company said. The FDA has not requested that Nuvo conduct any additional Phase III clinical trials.

Nuvo is also continuing discussions with the FDA to resolve other issues raised in the approvable letter, including the agency's conclusion regarding the adequacy of data on the dermal safety of the drug, the company said. Nuvo believes these issues were adequately addressed in its application, and that any FDA concerns should be dealt with via postapproval animal studies and/or labeling warnings. However, it is possible that the FDA may require Nuvo to conduct additional animal studies before approval to address these matters, resulting in a significant delay to submission of the company's response.

The FDA originally issued a not approvable letter for Nuvo's Pennsaid application, to which the company responded in June 2006. To meet the agency's requirements, Nuvo conducted a 12-week, Phase III, double-blind trial of 775 patients with primary osteoarthritis of the knee. The trial met all of its primary endpoints with respect to pain, physical function and patient overall health assessment. The company also conducted a long-term safety study of the drug.

Pennsaid is currently approved for the treatment of osteoarthritis in Canada and several European countries. The product allows diclofenac to be delivered to a specific site through the skin and thus limits complications associated with systemic delivery, according to Nuvo. There is currently no topical NSAID product approved in the U.S.