Delafloxacin enters Phase III study for Gonorrhea- Melinta Therapeutics
Melinta Therapeutics (formerly Rib-X Pharmaceuticals) has announced the initiation of a Phase III trial of delafloxacin, a novel investigational fluoroquinolone, for the treatment of uncomplicated Gonorrhea. The Phase III PROCEEDING (Prove Clinical Efficacy and Effectiveness of Delafloxacin in Neisseria Gonorrhoeae) program will assess the efficacy and safety of a single oral dose of delafloxacin compared to ceftriaxone (given in a single intramuscular injection).
Delafloxacin was designated a Qualified Infectious Disease Product (QIDP) by the FDA in this indication, as well as for ABSSSI. If approved for these indications, delafloxacin would receive an additional five years of extended market exclusivity (for a total of ten years), as provided for by the Generating Antibiotic Incentives Now (GAIN) Act of 2012.
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