Date: 2012-09-12
Type of information:
phase: 3
Announcement: results
Company: Cosmo Pharmaceuticals (Italy) Santarus (USA)
Product: rifamycin SV MMX®
Action mechanism:
Disease: travellers’ diarrhoea
Therapeutic area: Infectious diseases
Country:
Trial
details: The Phase III clinical study with rifamycin SV MMX® enrolled 264 patients in an international multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of rifamycin SV MMX® 400 mg (two oral tablets of 200 mg each) taken twice daily (800 mg total daily dose) for three days in the treatment of patients with travelers’ diarrhea.
Latest
news: Cosmo Pharmaceuticals has announced that the US licensee of rifamycin sV MMX®, Santarus, Inc. has announced that its Phase III clinical study to evaluate the safety and efficacy of the investigational drug, rifamycin SV MMX®, met the primary endpoints of reducing time to last unformed stool (TLUS) and achieving clinical cure (as defined in the study protocol) in the treatment of patients with travelers’ diarrhea.
In the intent-to-treat (ITT) population (n=264) the median TLUS was 46.0 hours for rifamycin SV MMX® (n=199) compared with 68 hours for placebo (n=65), p=0.0008. The percentage of patients that achieved clinical cure was 81.4% in the rifamycin SV MMX® treated group compared with 56.9% in the placebo group , p=<0.0001. Results in the per-protocol population (n=240) were similar to the ITT population.
Rifamycin SV MMX® was generally well tolerated in this phase III clinical study and the frequency of treatment emergent adverse effects was similar to placebo. Santarus expects additional data from this clinical study will be presented at an appropriate medical meeting in 2013.
Santarus has licensed rights to develop and commercialize rifamycin SV MMX® in the U.S. from Cosmo. Dr. Falk Pharma GmbH, Cosmo’s European development partner, is conducting a second Phase III clinical study to evaluate the efficacy of rifamycin SV MMX® versus ciprofloxacin on the primary endpoint of TLUS in patients with travelers’ diarrhea. This non-inferiority study is expected to enroll approximately 1,000 patients and to be completed in mid-2013. Santarus and Dr. Falk plan to share the clinical data from the two Phase III studies for inclusion in each company’s respective regulatory submissions.
