PennsaidTreatment for Osteoarthritis
Update: Pennsaid Now FDA Approved - November 4, 2009
Nuvo Continues Discussions with the FDA Related to Pennsaid
MISSISSAUGA, ON, June 05, 2007 /PRNewswire-FirstCall/ - Nuvo Research Inc. today announced that it is continuing discussions with the U.S. Food and Drug Administration ("FDA") to clarify and resolve matters raised by the FDA in its approvable letter (the "Approvable Letter") for Pennsaid issued on December 28, 2006. The discussions primarily concern the FDA's requirements for data to evidence the dermal safety of Pennsaid and its constituent components. While these discussions are ongoing, no definitive agreement has been reached with the FDA at this time. The Company will provide further updates as the steps toward Pennsaid approval are clarified.
In the Approvable Letter, the FDA confirmed that Pennsaid could be approved for sale in the U.S. once certain conditions were satisfied. 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.
Pennsaid 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 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 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. There is currently no topical NSAID product approved in the approximately $4 billion U.S. osteoarthritis pain relief market. In December 2006, the U.S. Food and Drug Administration issued an Approvable Letter that indicated Pennsaid is approvable subject to Nuvo satisfying certain conditions.
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, 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.
CONTACT: Investor Relations: Christina Bessant, Equicom Group Inc., (416)815-0700 x269, firstname.lastname@example.org
Ticker Symbol: (Toronto:NRI.)
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Posted: June 2007
- FDA Approves Pennsaid Topical Solution - November 5, 2009
- FDA Extends Review of Pennsaid Diclofenac Sodium Topical Solution - August 5, 2009
- FDA Accepts Nuvo's Resubmission For Pennsaid - February 19, 2009
- Nuvo Provides Update on Discussions with the FDA Related to Pennsaid Approval - June 19, 2007
- Nuvo announces further update on discussions with the FDA related to review of Pennsaid - March 7, 2007
- Nuvo Announces Update on Discussions With FDA Related to Approval of Pennsaid - February 9, 2007
- Nuvo Receives Approvable Letter From U.S. FDA for Pennsaid - December 29, 2006
- Nuvo’s Pennsaid NDA Resubmission Accepted for Review by U.S. FDA - July 13, 2006