The company anticipates completing its pivotal phase III trial for Pennsaid by the end of 2005. Preliminary results from the trial are likely to be disclosed in January 2006.
In anticipation of filing an amended new drug application for Pennsaid with the FDA in mid-2006, Nuvo has formed an FDA advisory panel to guide its submission. Dr Henrich Guntermann, Nuvo’s president and CEO said: “Our advisory panel has extensive experience with FDA submissions and will prove invaluable as we prepare for this event.”
Pennsaid, a topical non- steroidal anti-inflammatory (NSAID) used for the treatment of osteoarthritis, is approved for sale in Canada and several European countries. “If approved by the FDA, we believe Pennsaid will be the first topical NSAID to market in the US,” said Dr Guntermann.
Nuvo Research was formerly called Dimethaid Research until September 2004 when it changed its name following the sale of its subsidiary company Dimethaid Health Care to Paladin Labs. The Canadian Pennsaid license was also sold under the agreement, for which financial terms were not disclosed.