Nuvo Research Inc (MISSISSAUGA, Ontario) announced that it has received an approvable letter from the US FDA for Pennsaid® (1.5% w/w diclofenac sodium solution), a topical nonsteroidal anti-inflammatory (NSAID) for the treatment of osteoarthritis (OA) of the knee. Nuvo intends to meet with the FDA early in 2007 to discuss the conditions required to be met for drug approval and hopes to achieve commercial launch of Pennsaid by the end of the third quarter of 2007.

In July 2006, Nuvo resubmitted an amended new drug application (NDA) that addressed the specific deficiencies detailed in an August 2002 nonapprovable (NA) letter issued by the FDA with respect to Pennsaid. To meet the FDA's clinical efficacy and safety requirements as stated in the NA letter, Nuvo conducted a 12-week phase III, 5-arm, double-blind trial of 775 patients. This trial enrolled patients who had symptoms of primary OA of the knee and lived in the US and Canada. The trial met all its primary endpoints (pain, physical function, and patient overall health assessment) and also demonstrated Pennsaid's equivalency to the maximum daily dose of oral diclofenac in relieving pain and stiffness without provoking serious side effects. To address the long-term safety requirements as stated in the NA letter, Nuvo conducted a long-term multicenter, single-arm safety study of Pennsaid applied by patients with symptoms of OA of the knee. In total, 793 patients were treated, including 448 patients for at least 6 months and 116 patients for at least 1 year. The key observation was that long-term use did not cause any new, unexpected adverse events.

Pennsaid, the first medication based on Nuvo's patented transcellular technology, is used to treat OA pain and stiffness. The drug combines a proprietary chemical carrier with diclofenac sodium, a leading NSAID, and delivers active ingredient through the skin directly to the pain site. Pennsaid lotion has not been linked to the problems often found with conventional NSAID treatment. When used regularly, NSAID pills can cause numerous side effects. The most severe are ulcers and gastrointestinal bleeding, but they can also include blood pressure increases, dizziness, headache, depression, and delayed stomach emptying. With topically applied Pennsaid, the most common adverse reaction has been mild dryness or irritation at the application site. Pennsaid is currently approved for sale in Canada and the UK, Italy, Greece, Portugal, and the Caribbean.

In a separate announcement, Nuvo reported that Squire Pharmaceuticals Inc, a subsidiary of Paladin Labs Inc, has exercised its right to enter into a license with Nuvo to market and sell Pennsaid Plus in Canada. Squire obtained an option to license Pennsaid Plus as part of a previously announced transaction in January 2006 when Nuvo sold a portion of its Canadian Pennsaid revenue stream to Squire. Pennsaid Plus is a follow-on product to Pennsaid, and is designed to provide users with the efficacy of existing Pennsaid, but with less frequent dosing and increased ease of application. A pivotal phase III trial for the product is expected to begin in 2007. Squire currently markets and sells Pennsaid in Canada under license from Nuvo. Pennsaid sales in Canada grew 22% in 2006 to $10.5 million. The Pennsaid Plus license includes an up-front payment to Nuvo and royalties on future Canadian sales. As part of the licensing arrangement, Squire has also invested $500,000 in Nuvo through a 3-year debenture convertible into Nuvo shares.

—A. Techman

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