Rifaximin SSD

Rifaximin SSD (soluble solid dispersion) is an investigational, immediate-release formulation of the gut-selective antibiotic rifaximin, developed by Bausch Health through its subsidiary Salix Pharmaceuticals. This formulation (SSD-40IR) utilizes a solid dispersion technology designed to enhance the solubility of rifaximin within the gastrointestinal tract while maintaining its characteristic minimal systemic absorption. It was primarily evaluated in the Phase 3 RED-C clinical trial program, which consisted of two randomized, double-blind, placebo-controlled trials (RNLC3131 and RNLC3132) aimed at delaying the first episode of overt hepatic encephalopathy (OHE) in patients with liver cirrhosis and medically controlled ascites. Rifaximin works by binding to the beta-subunit of bacterial DNA-dependent RNA polymerase, thereby inhibiting bacterial RNA synthesis and reducing the population of ammonia-producing enteric bacteria. Although the drug demonstrated a safety profile consistent with existing rifaximin formulations, the RED-C trials failed to meet their primary efficacy endpoints.

Other names

Rifaximin Soluble Solid DispersionRifaximin SSD-40mg IR