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ProEthic Pharmaceuticals Announces Positive Phase I Trial Results for Fast-Acting Acute Pain Product Candidate; Trials Confirm Strong Pharmacokinetic Profile of PRO-571

Posted on: Thursday, 17 August 2006, 12:00 CDT

ProEthic Pharmaceuticals, Inc., a privately funded specialty pharmaceutical company that acquires, develops and markets niche prescription products, announced today positive results from two Phase I trials for PRO-571, the company's product candidate for the treatment of acute pain.

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 percent improvement over the 50 mg form diclofenac potassium currently available to patients. The study also showed an increased maximum blood concentration of approximately 125 percent over the 50 mg 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.

Carl Whatley, Chairman and CEO of ProEthic Pharmaceuticals Inc., stated, "We are excited to see that our sponsored trial confirmed the pharmacokinetic profile expected for PRO-571. 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. We will continue to work vigilantly to bring this product to the marketplace."

Next Steps

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.

About PRO-571

PRO-571 is an oral, Non-Steroidal Anti-Inflammatory Drug (NSAID) which utilizes a novel, rapid onset of action diclofenac potassium tablet for the treatment of acute pain. ProEthic has the exclusive marketing rights for PRO-571 in the United States and Canada. ProEthic licensed the product from Applied Pharma Research (Balerna, Switzerland) in mid-2005.

About ProEthic Pharmaceuticals, Inc.

ProEthic is a privately funded specialty pharmaceutical company that acquires, develops and markets niche prescription products. ProEthic markets branded prescription allergy, respiratory, pain and men's prostate vitamin products to general and family practitioners and selected specialty physicians in rural and suburban markets in 31 states. The company develops and commercializes proprietary formulations of previously approved compounds and selectively seeks regulatory approval to market well-characterized compounds for new therapeutic indications. ProEthic has built its product portfolio and development pipeline through a combination of internal development and acquisition of late-stage drug candidates. It also markets niche generic prescription pharmaceutical products through Midlothian Laboratories LLC, a wholly owned subsidiary. For more information, please visit the ProEthic website at: www.proethic.com.

Source: Business Wire

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