Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the Food and Drug Administration (FDA) has accepted for filing and designated for Priority Review the Company’s New Drug Application (NDA) for rifaximin tablets 550 mg for the maintenance of remission of hepatic encephalopathy (HE). Additionally, the FDA has informed the Company of its plan to schedule an Advisory Committee meeting in late February 2010 to discuss the application.
A Priority Review classification is granted to drugs offering major advances in treatment, or providing a treatment where no adequate therapy exists. Based on this classification, the FDA has issued an action date of December 24, 2009 under the Prescription Drug User Fee Act (PDUFA). However, the convening of an Advisory Committee in late February 2010 signals the December 24, 2009 action date will be delayed.
“We are pleased with the FDA’s acceptance for filing of the rifaximin NDA and their decision to grant Priority Review for our application,” stated Bill Forbes, Pharm.D., Senior Vice President and Chief Development Officer, Salix Pharmaceuticals. “This review classification signals that the FDA considers that rifaximin has the potential to provide a significant advance in the treatment of hepatic encephalopathy. We are not surprised at the FDA’s decision to convene an Advisory Committee to gain an independent recommendation from outside experts regarding rifaximin due to the fact that, if approved, rifaximin will be the first new option approved for the management of HE in over 30 years. We believe the availability of rifaximin has the potential to change the treatment paradigm for HE. Today’s news marks a milestone for Salix, rifaximin and patients suffering from this serious condition.”