PRO-571 is a unique, rapid-release formulation of diclofenac potassium in tablet form, which utilizes ProEthic’s Dynamic Buffering Technology (DBT). In two separate phase I studies, each enrolling 36 healthy volunteers, PRO-571 achieved an enhanced pharmacokinetic profile compared to currently marketed diclofenac potassium products.
These results demonstrated the product candidate’s potential to provide rapid relief to acute pain sufferers and confirmed results from a pilot pharmacokinetics study for the product candidate.
Peak blood levels were reached in approximately 22 minutes, a roughly 60% improvement over the 50mg form diclofenac potassium currently available to patients. The study also showed an increased maximum blood concentration of approximately 125% over the 50mg diclofenac potassium product. In addition, the phase I results showed that ProEthic’s formulation did not increase the overall extent of diclofenac exposure to healthy volunteers, an important endpoint in terms of product safety.
“We are excited to see that our sponsored trial confirmed the pharmacokinetic profile expected for PRO-571,” said Carl Whatley, chairman and CEO of ProEthic. “Patients and doctors have repeatedly rated time to onset of relief as one of the most important characteristics for a pain product, and we are pleased to be able to advance a product candidate with the demonstrated ability to bring this important clinical benefit to consumers and healthcare providers.”
ProEthic plans to initiate phase III trials in early 2007. If these trial results are positive, the company anticipates being able to file a marketing application for the product candidate in late 2007.