The study is being conducted under the guidance of a special protocol assessment (SPA) provided by the FDA. The SPA indicates that if the trial successfully meets its primary endpoints, the data will provide the basis for an efficacy claim in a marketing application to the FDA.
PRO-513 is a formulation of diclofenac potassium powder for oral solution, which utilizes a unique, patented 'dynamic buffering technology' that has been demonstrated to enhance the pharmacokinetic profile of diclofenac.
This new formulation is expected to offer migraine headache patients rapid pain relief combined with superior efficacy and tolerability. In a randomized, double-blind clinical trial, PRO-513 has been shown to provide systematic improvement of migraine symptoms within 15 minutes.
“PRO-513, and its unique formulation of diclofenac, represents a potentially new and improved treatment option for the 28 million Americans who experience debilitating migraine headaches,” said Carl Whatley, chairman and CEO of ProEthic.