ProEthic Pharmaceuticals Announces Acceptance Of New Drug Application For Migraine

Main Category: Headache / Migraine
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 14 Dec 2007 - 1:00 PDT

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ProEthic Pharmaceuticals, Inc., a privately funded specialty pharmaceutical company that acquires, develops, licenses and markets niche prescription products, announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's submission of its New Drug Application for PRO-513 for the treatment of migraine headaches. In accordance with the Prescription Drug User Fee Act (PDUFA), the FDA has set the goal date for their review as July 27, 2008.

PRO-513 is a patented formulation of diclofenac potassium powder for oral solution, which utilizes a unique, Dynamic Buffering Technology (DBT™) that has been demonstrated to enhance the pharmacokinetic profile of diclofenac. This formulation is expected to offer a new safe and efficacious prescription alternative for migraine patients.

"I am ecstatic about this milestone and I am so very proud of our ProEthic team for a job well done. Our organization has been described as the "little company that can" and this development further illustrates the passion, devotion and commitment of our employees. We are also thrilled about this potential new treatment option that may soon be available to millions of migraine sufferers throughout the country," said Carl Whatley, chairman and CEO of ProEthic Pharmaceuticals, Inc.

Technology Platform

PRO-513 utilizes ProEthic's Dynamic Buffering Technology (DBT™), which enhances the absorption of its active ingredient, diclofenac potassium. By utilizing bicarbonate, DBT enables diclofenac to enter the at a faster rate of absorption and increased peak plasma concentrations while not increasing the total amount of drug exposure for the patient compared to the 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 treatment altogether.

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 numerous countries outside of North America. Novartis expects dozens of additional marketing approvals outside the U.S. in 2008.

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.

ProEthic Pharmaceuticals