Salix Pharmaceuticals will initiate clinical trials after receiving permission from the FDA under the company’s recently filed Investigational New Drug for Granulated Mesalamine.

The Raleigh-based company says it plans to initiate preliminary dose characterization trials within the next several weeks and to initiate two Phase III studies by the end of the first half of 2004.

Salix intends to develop Granulated Mesalamine, a prolonged-release formulation of mesalamine, as a treatment for ulcerative colitis. The company already markets Colazal for the same purpose.

Salix licensed Granulated Mesalamine from Dr. Falk Pharma, which currently, markets the product in Germany under the trade name Salofalk Granu-Stix for the treatment of acute episodes and the maintenance of remission of ulcerative colitis.

Yesterday, the FDA told Salix it would decide by May 26 whether to approve Rifaximin, the company’s drug for the treatment for traveler’s diarrhea.