The FDA has fast-tracked Cempra Inc’s solithromycin intravenous (IV) and capsules to treat community acquired bacterial pneumonia (CABP), according to a company news release.
Solithromycin is currently in Phase 3 development for the treatment of CABP and submission of a New Drug Application (NDA) is planned for 2016, the company reported.
“We look forward to working with the FDA to streamline the development and review of this promising drug and we currently remain on track to release top line data from our Phase 3 solithromycin IV clinical study conducted in patients with CABP by the end of this year,” said Prabhavathi Fernandes, PhD, president and chief executive officer of Cempra.
The FDA’s Fast Track program was designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
Additional clinical studies with solithromycin include a Phase 3 trial in uncomplicated gonorrhea that is expected to complete patient enrollment by the end of 2015, a Phase 2 trial in chronic obstructive pulmonary disease (COPD), a Phase 2 trial in nonalcoholic steatohepatitis (NASH), and a Phase 1b trial in pediatric patients.
