Solithromycin is a novel fourth-generation macrolide antibiotic and the first fluoroketolide. A licensing application is expected to be submitted in US in 2016.
According to a commentary, the study has some important limitations. Firstly, the severity of community-acquired bacterial was mild for most patients, and for this group, guidelines would recommend a narrow spectrum antibiotic such as amoxycillin or doxycycline. It notes therefore that use of the broad-spectrum antibiotic moxifloxacin, not recommended in the UK because of the potential selection of Clostridium difficile, seems not to be the right comparator for solithromycin. The commentator discusses whether solithromycin is needed at all in view of its similar activity to recommended antibiotics, which will probably be substantially cheaper, and would likely not meet cost effectiveness thresholds set by NICE. He suggests that antibiotics need to be evaluated in a different way to other drugs as antibiotic resistance can rise rapidly and new antibiotics become vital. He highlights that as the development of an antibiotic takes 15 years, the process cannot start when the resistance is evident. He calls for a strategy that takes the development costs of pharmaceutical industry into account without ignoring the legitimate interests of society to have access to inexpensive medication.