Next-Generation Macrolide for CABP Under FDA Review
The Food and Drug Administration (FDA) has accepted for filing the two New Drug Applications (NDAs) for the intravenous and oral formulation of Solithera (solithromycin; Cempra) as a potential treatment for community-acquired bacterial pneumonia (CABP).
The NDA submissions were based on results from two Phase 3 safety and efficacy studies of oral and intravenous solithromycin in the treatment of CABP. Positive topline results from both trials were announced in 2015.
Solithromycin, the first fluoroketolide, is a highly potent next-generation macrolide with in vitro and in vivo activity against S. pneumonia, community-acquired methicillin resistantS. aureus (CA-MRSA), haemophilus, enterococci, Mycobacterium avium, gonococci, and atypical bacteria (eg, legionella, chlamydia, mycoplasma and ureaplasma). It is 8-16 times more potent than azithromycin against many bacteria and has activity against most macrolide-resistant strains.
For more information visit Cempra.com.