Drug intelligence / Profile preview

rifamycin SV-MMX

Development stage
Phase 4
Lead developer
Cosmo Pharmaceuticals
Modality
Small Molecules
Administration
Oral
01

Overview

Rifamycin SV-MMX is an oral, poorly absorbable, broad-spectrum antibiotic formulation that uses MultiMatrix (MMX) technology to enable targeted delivery to the distal small bowel and colon. This innovative formulation starts releasing the active ingredient only after reaching intestinal pH levels of ≥7, with an additional 1-hour delay, specifically targeting the distal small bowel and colon[1][3]. ## Key Features The drug exhibits antibacterial activity against a broad spectrum of clinically relevant enteropathogens, including noninvasive strains of E. coli that cause traveler's diarrhea[2][3]. Its unique pharmacokinetic properties ensure that less than 1% of the administered dose is absorbed systemically after oral administration, allowing it to work locally in the intestinal lumen[1][3]. ## Clinical Efficacy In clinical trials, Rifamycin SV-MMX has demonstrated effectiveness in shortening the duration of non-dysenteric traveler's diarrhea in adults. Phase III studies showed it was significantly more effective than placebo and noninferior to ciprofloxacin in reducing median time to last unformed stool (TLUS)[3]. The standard dosage for treating traveler's diarrhea is 400 mg twice daily for 3 days[1][3]. ## Availability and Marketing Rifamycin SV-MMX is approved in both the EU and the US for the treatment of traveler's diarrhea. In the US, it is marketed under the brand name Aemcolo, containing 200 mg of rifamycin sodium (equivalent to 194 mg of rifamycin)[6][9]. In 2023, Adalvo and Cosmo Pharmaceuticals announced a collaboration to extend the reach of this treatment to Europe, Asia-Pacific, Middle East/North Africa, and Latin America regions[6]. ## Safety Profile Due to its minimal systemic absorption, Rifamycin SV-MMX is generally well tolerated, with the overall incidence of treatment-emergent adverse events similar to those of placebo and ciprofloxacin in clinical trials[3]. ## Additional Research Recent research has also explored the potential use of Rifamycin SV-MMX in other conditions. A 2024 phase 2 randomized clinical trial investigated its effects on muscle mass, physical function, and ammonia levels in patients with cirrhosis and minimal encephalopathy, suggesting potential applications beyond traveler's diarrhea[7]. --- Rifamycin SV-MMX is an oral, poorly absorbable, broad-spectrum antibiotic belonging to the class of ansamycins. It uses MultiMatrix (MMX) technology to enable targeted delivery to the distal small bowel and colon, where it acts locally in the intestinal lumen with minimal systemic absorption. The formulation starts releasing the active ingredient only after reaching intestinal pH levels of ≥7, with an additional 1-hour delay. It is primarily indicated for the treatment of traveler's diarrhea caused by noninvasive strains of E. coli.

Brand names
AemcoloRelafalk
Other names
rifamycin sodium MMX
02

Targets

rpoB (DNA-directed RNA polymerase subunit beta)

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