Ketoprofen patch agreement signed for joint pain treatment

Published: 1-May-2003
Regulatory


ProEthic Laboratories, of Montgomery, Alabama, and Swiss drug delivery company Applied Pharma Research have signed a licensing agreement for a once-daily transdermal version of the NSAID ketoprofen. The patch, which is as yet unnamed, aims to relieve joint pain without the gastrointestinal discomfort often associated with oral analgesics. It resembles a small piece of bandaging tape and provides a steady, continuous influx of the active drug directly to the inflamed area.

Under the agreement ProEthic will have exclusive rights to market the product in the US, and will oversee its clinical development there with a NDA submission scheduled for late next year. Worldwide rights excluding the US, Canada and Japan, were licensed by Applied Pharma Research to the Italian Zambon Group in 2001. In a recently completed Phase III clinical trial in France and Belgium, the patch was shown to be effective in patients with periarticular soft tissue pain, such as tendonitis and bursitis. Results from a second trial aimed at assessing the drug's efficacy on ankle sprains, are expected imminently, after which the Zambon Group will submit the drug for EC approval.

The European market for topical anti-inflammatory drugs is valued at more than €500m (US$540m). While no topical or transdermal NSAID has received FDA approval, industry estimates project the potential US market at $200-300m (€187-280m).

'We believe the ketoprofen patch has tremendous domestic potential,' said Carl Whatley, ceo of ProEthic. 'There is already strong clinical evidence of its effectiveness in relieving pain, but perhaps even more impressive is its capacity to eliminate stomach distress, which often prohibits many patients from taking NSAIDs.'

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