Action date of XIFAXAN® expected on March 24 (Nasdaq:SLXP)

On August 24, 2009, Salix Pharmaceuticals, Ltd. (NASDAQ: SLXP) disclosed that the FDA had found that the new drug application (NDA) – that was submitted for the company’s recently developed rifaximin tablets 550 mg (called XIFAXAN^®)– contained  all the information that would allow it to make a thorough review on the drug. This meant that the NDA of rifaximin was accepted for filing. At that time, the FDA decided to start the Priority Review of the NDA.

The regulator also handed out a Prescription Drug User Fee Act date – also called Action date or just PDUFA date – of December 24, 2009. This was the date on which the FDA was expected to complete the Priority Review and to provide a response on the NDA to Salix. The stakeholders of Salix were eagerly looking forward to this date. Although the date got extended to February 23, 2010, the final results were favorable for Salix. XIFAXAN^® was clearly approved by the FDA’s Gastrointestinal Drugs Advisory Committee. 14 members of the committee voted for XIFAXAN® – compared with only 4 members who did not approve the drug. Salix also disclosed that the regulator had provided it with an Action date of March 24, 2010. This is the date by which the FDA will finish reviewing the complete NDA application and let the company know whether XIFAXAN® can be brought into the US markets or not.

Before providing its decision, the Gastrointestinal Drugs Advisory Committee investigated the results from the Phase 3 trial that Salix had conducted. The trial was “double–blind, placebo–controlled” and measured the safety and the effectiveness of the drug in treating Hepatic encephalopathy (HE). It was conducted in multiple centers in a number of countries throughout the world. About 299 people suffering from HE participated in the trial.

Right after the news of the approval by the committee came out, Bill Forbes, Pharm.D., who is the Chief Development Officer (CDO) and also the Senior Vice President of Salix Pharmaceuticals, said:

“We are very pleased with the advisory committee’s support for the approval of XIFAXAN 550 mg tablets. If approved, XIFAXAN 550 mg will be the first new option for the management of hepatic encephalopathy in over 30 years. We believe the availability of XIFAXAN 550 mg has the potential to change the treatment paradigm for HE. Today’s independent recommendation from the outside experts comprising the advisory committee reinforces the Company’s confidence in the potential for XIFAXAN 550 mg to provide a solution for patients suffering from this serious condition.”