MISSISSAUGA, ON, April 26 /PRNewswire-FirstCall/ - Nuvo Research Inc. today announced it has completed its analysis of the data from its Phase III long-term, open-label safety trial ("Study 112E") for Pennsaid(R).
"A full analysis of the results from our 52 week safety trial has now been completed and confirms the safety profile of Pennsaid(R)," 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 U.S. NDA re-submission for Pennsaid(R), which remains on track for mid-2006."
Pennsaid(R) (1.5% w/w diclofenac sodium solution) is a topical non-steroidal anti-inflammatory (NSAID) used for the treatment of osteoarthritis and is currently approved for sale in Canada and several European countries. Study 112E was a long-term multi-centre, single-arm safety study of Pennsaid applied by patients with symptoms of osteoarthritis (OA) of the knee. 793 patients in total were treated, 448 patients for at least 6 months and 116 patients for at least one year, satisfying the standard International Conference for Harmonisation (ICH) long-term safety requirements.
Over the course of the study, pre-defined safety parameters were prospectively monitored and patient reported adverse event information was collected at regularly scheduled visits. Parameters included patient history and routine physical examination, standard blood and urine tests and full ocular examination.
The results of this long-term safety trial confirm the safety profile of Pennsaid evidenced in the previous 3-month safety/efficacy pivotal trials. The most prevalent adverse event noted was application site skin irritation in the form of dry skin - as has been observed in previous trials and is noted in both the Canadian and European product labels. As anticipated, with prolonged, continuous use more patients experienced some application site skin reaction. The key observation was that long-term use did not cause any new, unexpected adverse event.
About Nuvo Research Inc.
Nuvo is focused on developing innovative site-specific therapeutics that are delivered topically using the Company's skin-penetrating technologies. Nuvo's lead product is Pennsaid(R), a topical non-steroidal anti-inflammatory (NSAID) used for the treatment of osteoarthritis. Nuvo intends to leverage its skin-penetrating technologies to create a portfolio of transdermal products targeting a variety of indications.
Nuvo Research Inc. is a publicly traded, Canadian pharmaceutical company headquartered in Mississauga, Ontario, with manufacturing facilities in Varennes, Quebec and Wanzleben, Germany. For more information, please visit www.nuvoresearch.com.
This release may contain forward-looking statements, subject to risks and uncertainties beyond management's control. Actual results could differ materially from those expressed here. Risk factors are discussed in the Company's annual information form filed with the securities commissions in each of the provinces of Canada. The Company undertakes no obligation to revise forward-looking statements in light of future events.
Nuvo Research Inc.CONTACT: Investor Relations: Christina Bessant, Equicom Group Inc., (416)815-0700 x269, cbessant@equicomgroup.com; Archived images on thisorganization are searchable through CNW Photo Archive website athttp://photos.newswire.ca. Images are free to accredited members of themedia. To request a free copy of this organization's annual report, pleasego to http://www.newswire.ca and click on Tools for Investors.
