PROETHIC ANNOUNCES RESULTS OF PAIN DRUG TRIAL

ProEthic Pharmaceuticals has announced the results from two Phase I trials for PRO-571, the company's product candidate for the treatment of acute pain.

PRO-571, an oral, non-steroidal anti-inflammatory drug (NSAID), is a rapid-release formulation of diclofenac potassium in tablet form, made using 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 with currently marketed diclofenac potassium products.

Peak blood levels were reached in approximately 22 minutes, a roughly 60 percent improvement over the 50 mg form diclofenac potassium currently available. The study also showed an increased maximum blood concentration of approximately 125 percent over the 50 mg diclofenac potassium product. In addition, the results showed that ProEthic's formulation did not increase the overall extent of diclofenac exposure to healthy volunteers, an important end point in terms of product safety.