The first poster presentation provided efficacy and tolerability results from a Phase III clinical study for PRO-513, a randomized, double-blind, placebo-controlled trial that enrolled 690 adult patients.
The two-hour pain free response among patients, the primary efficacy endpoint of the trial, was 25 percent in the PRO-513 arm of the trial versus 10 percent for the placebo arm (P less than 0.001). In addition, the two-hour pain headache response for the PRO-513 arm of the trial was 65 percent, compared with 41 percent for the placebo group. Statistically significant differences in pain intensity difference (PID) scores emerged at 30 minutes (P=0.013) and the PID remained significant at P less than 0.001 at each of the subsequent 10 time points measured.
The findings also demonstrated that the proportion of patients who were free of symptoms accompanying migraine was statistically significant for PRO-513 compared to placebo at two hours for nausea (P=0.002), photophobia, or sensitivity to light (P less than 0.001) and phonophobia, or sensitivity to sound (P less than 0.001).
The second poster presentation detailed positive secondary endpoint results from the Phase III trial, including results from the 24-hour sustained pain-free response and 24-hour sustained headache response.
In the trial, significantly more patients in the PRO-513 arm achieved a 24-hour sustained pain-free response, than in the placebo arm. Among patients who were pain free at two hours, almost 80% had persistent benefits without headache recurrence or need for rescue medication.. In addition, the number of patients in the PRO-513 arm who were able to perform all daily activities increased eleven-fold from baseline to two hours and over 18 times within 24 hours.
Adverse events in the Phase III trial were comparable between the PRO-513 and placebo arms and were generally mild to moderate in severity. No serious adverse events were reported. The results were similar for the intent-to-treat group and the per protocol population.
"PRO-513 was able to meet all of its co-primary endpoints as well as key secondary endpoints in its Phase III trial," Dr. Richard Lipton stated. "With its ability to rapidly relieve the pain of migraine and the associated symptoms, PRO-513 would represent an important first line treatment option for migraine sufferers were it to be approved."
Carl Whatley, Chairman and CEO of ProEthic Pharmaceuticals, stated, "The findings presented today will serve as the basis for our New Drug Application for PRO-513, which will be filed by the end of the second quarter. The market for migraine therapies is significant, yet filled with a high degree of patient dissatisfaction. If approved, we believe PRO-513 would advance the standard of care in migraine treatment by providing distinct advantages over current therapies in both efficacy and tolerability."
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(R).
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 treatment 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(R) or Catafast(R) 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
ProEthic Pharmaceuticals, Inc.
Lauren Vinson, 334 -288-1288
Director of Public Relations