Drug news
Omadacycline (Paratek Pharma) special protocol with FDA is agreed for Phase III study for ABSSSI and CABP
Paratek Pharmaceuticals has reached agreement with the FDA on its second Special Protocol Assessment (SPA) related to the Phase III program design for the Company's lead antibiotic candidate, omadacycline (formerly PTK 0796). Omadacycline is a broad-spectrum, first-in-class aminomethylcycline antibiotic with oral and IV formulations that Paratek is developing to address the leading organisms that cause bacterial infections such as serious (acute) bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP), including those caused by resistant bacteria. Novartis have world rights to this drug.Omadacycline will be the subject of several poster presentations at the 22nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) being held in London from March 31-April 3, 2012