PRO-513 is a formulation of diclofenac potassium powder for oral solution, which utilizes a unique, patented Dynamic Buffering Technology (DBT) 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.
Migraine headache is a debilitating disease affecting more than 28 million people in the US alone. There is, as yet, no cure, although medications can alleviate the degree of pain and frequency of onset.
According to ProEthic, this improved formulation may offer rapid relief of headache, as well as other associated symptoms such as photophobia (sensitivity to light), phonophobia (sensitivity to sound), and nausea.
For this trial, ProEthic will enroll 650 patients in about 21 centers within the next 8 months. Pending results, ProEthic hopes to be able to file a New Drug Application (NDA) for PRO-513 early next year and expects to begin manufacturing in early 2008.
Source: ProEthic
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