Oral solithromycin: Phase III started

Cempra began the open-label, U.S. and Australian Phase III Solitaire-U trial to compare single doses of 1,000 mg oral solithromycin vs. standard of care (SOC) in about 300 patients with uncomplicated N. gonorrhoeae infection, with or without a concomitant C. trachomatis infection. SOC comprises a single intramuscular of 500 mg ceftriaxone plus a single dose of 1,000 mg oral azithromycin.

FDA granted Qualified Infectious Disease Product (QIDP) designation for an oral formulation of solithromycin to treat gonorrhea and community-acquired bacterial pneumonia (CABP), for which it is in Phase III testing (see BioCentury, Sept. 16, 2013). Cempra is also conducting an IV-to-oral step-down Phase III trial of solithromycin. ...