ARTICLE | Clinical News

Oral solithromycin: Completed Phase III enrollment

November 10, 2014 8:00 AM UTC

In September, Cempra completed enrollment of 860 CABP patients in the double-blind, international Phase III Solitaire-Oral trial comparing once-daily oral solithromycin for 5 days vs. oral moxifloxicin for 7 days. Patients will receive 800 mg solithromycin on day 1 and 400 mg thereafter.

FDA granted Qualified Infectious Disease Product (QIDP) designation for an oral formulation of solithromycin to treat CABP and gonorrhea, 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. ...