Currently, solithromycin is in Phase III development for the treatment of CABP and submission of a new drug application (NDA) is planned for 2016.
The company is carrying out additional clinical trials with solithromycin including a Phase III trial in uncomplicated gonorrhea that is expected to complete patient enrollment by this year end, a Phase II trial in chronic obstructive pulmonary disease (COPD), a Phase II trial in nonalcoholic steatohepatitis (NASH), and a Phase Ib trial in pediatric patients.
Cempra president and chief executive officer Prabhavathi Fernandes said: "We are pleased that the FDA has granted Fast Track status for solithromycin IV and capsules in the treatment of CABP.
"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 III solithromycin IV clinical study conducted in patients with CABP by the end of this year."
Earlier, the FDA has designated solithromycin IV and capsules to treat CABP and solithromycin capsules for gonorrhea as a qualified infectious disease product (QIDP).
If finally approved by the FDA, solithromycin would be eligible for an additional five-year extension of Hatch-Waxman new chemical entity exclusivity.