FDA Grants ‘Fast Track’ Designation to Antibiotic Cadazolid for Treatment of Diarrhea
Phase III studies compare cadazolid and vancomycin (February 27)
The FDA has designated cadazolid as both a qualified infectious disease product (QIDP) and a “fast track” candidate for the treatment of Clostridium difficile-associated diarrhea (CDAD).
The QIDP designation for cadazolid means that — among other incentives — the antibiotic will receive a 9-month priority review upon successful completion of the ongoing phase III IMPACT (International Multicenter Program Assessing Cadazolid Treatment) program. The fast track designation is intended to promote communication and collaboration between the FDA and the manufacturer (Actelion) on the drug's development.
The IMPACT program consists of two phase III studies comparing the efficacy and safety of cadazolid (250 mg administered orally twice daily for 10 days) with that of vancomycin (125 mg administered orally four times daily for 10 days) in patients with CDAD.
The IMPACT studies are designed to determine whether the clinical response after the administration of cadazolid is non-inferior to that of vancomycin in subjects with CDAD, and whether the administration of cadazolid is superior to vancomycin in terms of a sustained clinical response. The program is expected to enroll approximately 1,280 subjects worldwide. Enrollment began in the fourth quarter of 2013.
Cadazolid is an inhibitor of C. difficile protein synthesis, which leads to the suppression of toxin and spore formation. In preclinical studies, the antibiotic showed in vitro activity against C. difficile clinical isolates and a low propensity for the development of resistance. In a human gut model of CDAD, cadazolid had a limited effect on the normal gut microflora.
Source: Actelion; February 27, 2014.