The phase III trial, named Study 112E, was a long-term multi-center, single-arm safety study of Pennsaid applied by patients with symptoms of osteoarthritis (OA) of the knee. In the trial, 793 patients in total were treated, 448 patients for at least six months and 116 patients for at least one year.
“A full analysis of the results from our 52-week safety trial has now been completed and confirms the safety profile of Pennsaid,” said Dr Henrich Guntermann, Nuvo’s president and CEO. “These results along with the positive clinical efficacy results we have reported will form a major part of our US NDA re-submission for Pennsaid, which remains on track for mid-2006.”
Pennsaid (1.5% w/w diclofenac sodium solution) is a topical non-steroidal anti-inflammatory (NSAID) used for the treatment of OA and is currently approved for sale in Canada and several European countries.