MISSISSAUGA, ON, June 19 /PRNewswire-FirstCall/ - Nuvo Research Inc. today announced additional information related to the expected path forward to Pennsaid approval by the U.S. Food and Drug Administration (“FDA”).
In recent communications, the FDA has clarified certain of its requirements for additional information relating to Pennsaid. As a result, 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 FDA in the first half of 2009 and be eligible to receive final marketing approval in the second half of 2009. 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 FDA minutes will confirm the written correspondence received from the FDA.
In the Approvable Letter, the FDA confirmed that Pennsaid could be approved for sale in the U.S. once certain conditions were satisfied, including the provision of additional dermal safety data. None of the conditions relate to clinical efficacy or clinical safety of Pennsaid, which were evidenced in Nuvo’s Phase III trials. The FDA has not requested that Nuvo conduct any additional Phase III clinical trials.
About Pennsaid(R)
Pennsaid(R) is a topical non-steroidal anti-inflammatory drug (NSAID) for the treatment of osteoarthritis and is currently approved for sale in Canada and several European countries. Pennsaid(R) allows the diclofenac solution to be delivered to a specific site via the surface of the skin. The systemic exposure of Pennsaid is approximately 1/200th of that from the oral dosage form of diclofenac, greatly decreasing the potential for complications associated with the oral route of delivery. According to published clinical trials, Pennsaid(R) is as effective as the maximum daily dose of comparable oral medication at relieving pain and stiffness associated with osteoarthritis of the knee, as well as improving overall well-being.
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 drug (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 and a research and development facility in San Diego, California. 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
