Nuvo Research Inc (MISSISSAUGA, Ontario) announced that it has resubmitted its New Drug Application (NDA) for PennsaidR (1.5% w/w diclofenac sodium solution), a topical nonsteroidal anti-inflammatory (NSAID) used for the treatment of osteoarthritis (OA) of the knee to the US FDA. The FDA has indicated that its goal date to complete its review of the resubmission is December 28, 2006. The resubmission is a complete Class 2 response to the deficiencies outlined in an August 2002 Non-Approvable (NA) letter issued by the FDA with respect to Pennsaid.
The NDA resubmission contains data collected from recent efficacy and safety trials. To meet the FDA's clinical efficacy and safety requirements as stated in the NA letter, Nuvo conducted a 12-week phase III, 5-arm, double-blind trial of 775 patients. This trial enrolled patients in the US and Canada with symptoms of primary OA of the knee. The trial met all of its primary endpoints, being pain, physical function, and patient overall health assessment. The trial also demonstrated comparable efficacy of Pennsaid to oral diclofenac. To address the long-term safety requirements as stated in the NA letter, Nuvo conducted a long-term, multi-center, single-arm safety study of Pennsaid applied by patients with symptoms of OA of the knee. In total, 793 patients were treated, including 448 patients for at least 6 months and 116 patients for at least 1 year. The key observation was that long-term use did not cause any new, unexpected adverse events.
Pennsaid, the first medication based on Nuvo's patented transcellular technology, is used to treat OA pain and stiffness. The drug combines a proprietary chemical carrier with diclofenac sodium, a leading NSAID and delivers active ingredient through the skin directly to the pain site. Pennsaid lotion has not been linked to the problems often found with conventional NSAID treatment. When used regularly, NSAID pills can cause numerous side effects. The most severe are ulcers and gastrointestinal bleeding, but they can also include increases in blood pressure, dizziness, headache, depression, and delayed stomach emptying. With topically applied Pennsaid, the most common adverse reaction has been mild dryness or irritation at the application site. A recent equivalence study has also shown that Pennsaid works as well as the maximum daily dose of oral diclofenac, without provoking serious side effects.
Pennsaid is currently approved for sale in Canada and the UK, Italy, Greece, Portugal, and the Caribbean.