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news.Astellas Pharma's Dificlir has demonstrated similar efficacy and tolerability profile to oral vancomycin, while providing the benefit of sustained response and reduction in rates of recurrence, according to The Lancet Infectious Diseases.
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In a multi-center double-blind randomized non-inferiority Phase III trial known as Study OPT-80-004, 509 adults with Clostridium difficile infection (CDI) received 400mg/day oral Dificlir or 500mg/day oral vancomycin for ten days.
The study showed that patients treated with Dificlir reported lower rate of CDI recurrence within 30 days after completion of therapy compared to those receiving vancomycin.
In addition, Dificlir recipients experienced a greater sustained response than those treated with vancomycin.
The University of Cologne, Germany, Clinical Trial Center medical director Oliver Cornely said in the study, Dificlir reduced disease recurrence compared to vancomycin, the current standard of care, showing promise as an effective treatment alternative for patients with CDI.
Another trial, Study OPT-80-003, also showed that Dificlir was non-inferior to vancomycin in terms of clinical cure and also associated with a lower rate of CDI recurrence.