ProEthic Pharmaceuticals Announces Positive Phase III Clinical Trial Results for Fast-Acting Migraine Product Candidate
- All Trial Endpoints Achieved -
MONTGOMERY, Ala. -- ProEthic Pharmaceuticals, Inc., a privately funded specialty pharmaceutical company that acquires, develops, licenses and markets niche prescription products, announced today successful Phase III clinical trial results for PRO-513, its product candidate for the treatment of migraine headaches. These findings will serve as the basis for a New Drug Application (NDA) for PRO-513, expected to be filed with the U.S. Food and Drug Administration in early 2007.
In an eight month randomized, double-blind, placebo-controlled trial that enrolled 690 adult patients, PRO-513, a proprietary formulation of diclofenac potassium powder for oral solution, reached all of its primary endpoints by achieving statistical superiority to placebo in pain relief and the associated symptoms of nausea, photophobia or sensitivity to light and phonophobia, or sensitivity to sound at two hours for all conditions. PRO-513 was well tolerated in the study, with no safety issues reported.
“These trial results are a significant achievement for ProEthic and a critical step forward in our efforts to improve the treatment options available to the 30 million Americans who experience migraine headaches,†said Carl Whatley, Chairman and CEO of ProEthic Pharmaceuticals, Inc. “These results add to the extensive body of clinical data demonstrating PRO-513’s potential advantages over current treatments in safety and efficacy, as well as its ability to offer the more rapid form pain relief sought by migraine sufferers and their physicians. We are thrilled at the performance by our clinical team in successfully completing this study and look forward to working with the FDA on the approval for this product candidate.â€
Secondary endpoints from the trial confirmed PRO-513’s ability to offer rapid and sustained migraine pain relief. Approximately 65 percent of patients on PRO-513 had an improvement in headache response scores within two hours compared to only 40 percent of placebo patients. Statistically significant pain relief was achieved within 30 minutes of treatment. PR0-513 also achieved statistical superiority versus placebo in the percent of patients that remained sustained pain free for the entire 24 hours observation period.
Richard B. Lipton, MD, Professor and Vice Chair of Neurology at the Albert Einstein College of Medicine and Director of the Montefiore Headache Center and study principal investigator, said, "The results are good news for migraine sufferers. Diclofenac, in this new formulation, rapidly relieved the pain of migraine and the associated symptoms, including nausea, sensitivity to light and sensitivity to sound."
Technology Platform
PRO-513 utilizes ProEthic’s patented Dynamic Buffering Technology (DBT), which enhances the absorption of its active ingredient, diclofenac potassium. By utilizing potassium bicarbonate as a localized buffer, DBT enables diclofenac to enter the bloodstream more quickly, resulting in a faster rate of drug absorption and increased peak plasma concentrations while not increasing the total amount of drug exposure for the patient compared to currently marketed reference drug, Cataflam®.
About Migraines
Migraine headaches affect an estimated 30 million people in the United States and disproportionately affect women 3 to 1. According to a recent peer reviewed publication authored by leading migraine researchers, more than 70 percent of patients indicated that they were less than completely satisfied with their current treatment. Over 85 percent complained that pain relief took too long and 25 percent decided to stop seeking treating all together.
PRO-513 Development History
In 2005, ProEthic obtained exclusive U.S. and Canadian marketing rights for PRO-513 from APR, Applied Pharma Research, a Swiss drug delivery and drug development company. The product candidate is currently marketed by Novartis Pharma AG, under the trademarks Voltfast® or Catafast®in Switzerland, Italy, Egypt and Portugal. Novartis has also recently received marketing approval in a dozen additional countries outside of North America and expects to receive over two dozen additional approvals during 2007.
About ProEthic Pharmaceuticals, Inc.
ProEthic is an emerging specialty pharmaceutical company enhancing treatment strategies initially in the areas of pain and migraine. Founded in 2001, the privately held company focuses its efforts on the acquisition, development, licensing, and marketing of pharmaceutical products. ProEthic 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.