Adult OM/PJI due to MRSA are among the most hard-to-treat MRSA infections due to the difficulties for the body’s natural infection-fighting cells and antibiotics to reach the infected tissues in the bones. However, there is no guidance published by the FDA or the EMA to help drug developers to design clinical trials testing antibiotics for OM/PJI. Indeed, no new antibiotic has been approved for the treatment of OM/PJI by the FDA or EMA in the last two decade, and only a few clinical trials have been conducted to evaluate antibiotics’ efficacy and safety/tolerability for OM/PJI. The lack of approved labels and the paucity of relevant clinical efficacy and safety data force managing physicians to rely on their own experience to select antibiotics for a protracted therapy required for adult OM/PJI due to MRSA, representing a significant unmet need in this field.
Markets covered: United States, United Kingdom, France, Germany
Primary research: Survey of 60 U.S. and 31 European ID specialists fielded in January 2017
Key companies: Allergan, Cempra, Merck, Pfizer
Key drugs: vancomycin, daptomycin, dalbavancin, linezolid, ceftaroline, Taksta, rifampin, TMP/SMX