Nuvo's Pennsaid “Approvable” For Osteoarthritis
This article was originally published in The Pink Sheet Daily
Executive Summary
Company plans to meet with FDA in early 2007 to discuss the topical non-steroidal anti-inflammatory treatment.
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Nuvo Research's topical non-steroidal anti-inflammatory drug Pennsaid (1.5% diclofenac sodium solution) is "approvable" for treatment of osteoarthritis of the knee, the company announced Dec. 29. The Ontario, Canada company has requested a meeting with FDA in early 2007 to discuss outstanding issues surrounding the NDA. "We plan to work closely with the FDA to resolve these outstanding matters required to obtain final approval and expect to provide further information following our meeting with the FDA," the company reported. The approvable letter was issued by FDA in response to Nuvo's NDA resubmission in July; the company received a "not approvable" letter from the agency for Pennsaid in August 2002. In the most recent submission, Nuvo included data from a new 12-week Phase III study, enrolling 775 patients, which was conducted to address FDA's long-term safety concerns (1 (Also see "Pennsaid Amended NDA Has Mid-December User Fee Date" - Pink Sheet, 14 Jul, 2006.)). Pennsaid employs Nuvo's proprietary transcellular delivery technology that allows diclofenac to be delivered directly to the knee via a topical application to the skin. It is already approved in Europe and Canada. Effective Dec. 1, Paladin Labs took over full Canadian sales and marketing responsibilities for Pennsaid from Solvay Pharma; the two companies previously had a copromotional agreement (2 (Also see "Paladin Assumes All Canadian Marketing Of Nuvo’s Pennsaid" - Pink Sheet, 1 Dec, 2006.)). - Jessica Merrill ([email protected]) |