Nuvo Research updates on Pennsaid talks with FDA

Ontario, Canada-based Nuvo Research says that, in recent communications, the US Food and Drug Administration has clarified certain of its requirements for additional information relating to its New Drug Application for Pennsaid (diclofenac, topical). As a result, the firm's management intends to commence all requested long-term dermal animal studies and believes that the longest study can be completed post approval, provided no safety concerns have arisen from any of the studies prior to resubmitting the application for Pennsaid approval.

These communications have been confirmed in written correspondence from the FDA, but have not yet been recorded in official FDA minutes, which Nuvo expects to receive in the coming weeks. On the basis of this clarification, Nuvo anticipates that it will be in a position to complete all necessary studies and file a complete resubmission of its application for Pennsaid approval with the agency in the first half of 2009 and be eligible to receive final marketing approval in the second half of 2009.

Nuvo adds that there can be no assurance that these anticipated timelines will be achieved, as they are dependant on a number of factors, including successful completion of other shorter studies to address other conditions within the "approvable" letter, nor can there be any assurance that the official minutes will confirm the written correspondence received from the FDA.