SAN DIEGO Victory Pharma announced that the U.S. Food and Drug Administration has agreed to review its New Drug Application MGX006.
MGX006 is a proven antiemetic agent typically used to treat nausea and vomitting.
"Acceptance of the MGX006 is a significant milestone, it demonstrates Victory's ability to grow its commercial portfolio via internal product development in addition to in-licensing products," said Matt Heck, CEO of Victory. "Pending FDA approval, we are planning for a first half of 2010 product launch, allowing Victory to further leverage its 150 person field sales organization. Given many patients suffering from pain also suffer from emesis, there is a good fit between MGX006 and Victory's growing, pain management franchise."
Approximately 25 million prescriptions are written annually in the U.S. for antiemetic therapeutics, many of which are taken orally and can cause problems amongst patients. If approved, MGX006 will offer those suffering with emesis with an alternative medication option.