New Treatment for Community Acquired Pneumonia

Cempra's solithromycin has recently received fast-track status from the FDA. Solithromycin is a next-generation macrolide, a fluoroketolide, which has strong activity against macrolide-resistant bacterial strains.

A New Drug Application is expected in 2016 for the treatment of community-acquired bacterial pneumonia. Solithromycin, otherwise known as CEM-101, is under phase 3 trials for this indication. Under the GAIN (Generating Antibiotic Incentives Now)  law, solithromycin was granted status as a Qualified Infectious Disease product. Both IV solution and oral capsules obtained this status for the treatment of community acquired pneumonia, while the capsules obtained QIDP status for the treatment of gonorrhea.

Aside from its phase 3 trials for CABP, solithromycin is also undergoing a phase 3 trial for uncomplicated gonorrhea, phase 2 for COPD and nonalcoholic steatohepatitis, and phase 1 trial in pediatric populations. Thus far, studies have shown solithromycin to be a well-tolerated and safe treatment.

Source:
http://www.pharmacytimes.com/product-news/bacterial-pneumonia-treatment-fast-tracked-by-fda