Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID) generally used for the treatment of inflammation and pain and available in the US only in oral form. Under the terms of the agreement for the ketoprofen product, Endo will make a $10.0 million upfront payment and payments of approximately $14.0 million for the achievement of certain regulatory milestones.
Currently in phase II clinical trials in the US, the topical ketoprofen patch is being developed for the localized treatment of acute pain associated with soft-tissue injuries such as tendonitis or joint sprains and strains.
Two phase III placebo-controlled studies in soft-tissue injury and ankle sprains have been completed in Europe by ProEthic’s European partner Applied Pharma Research AG, with statistically significant results.
“We believe that the topical ketoprofen patch, which bypasses the bloodstream, could also offer the added benefit of targeted pain control aimed directly at the injury site with the convenience of once-a-day dosing,” said Peter Lankau, Endo’s president and COO. “We would expect that this has the potential to be an attractive product opportunity compared to systemic agents.”
The total soft-tissue injury market is currently estimated to be approximately $2.5 billion, primarily consisting of NSAID’s and COX-2s.