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ProEthic Pharmaceuticals Presents Positive Data for PRO-513 at,American Headache Society Meeting

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."

Technology Platform

PRO-513 utilizes ProEthic's patented Dynamic Buffering Technology (DBT), which enhances the absorption of its active ingredient, diclofenac potassium.
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