The Company’s lead commercial product, NUZYRA® (omadacycline), which has launched and is available in the U.S., is a once-daily oral and intravenous antibiotic for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.
The Company has agreed on a path forward with the FDA to evaluate an oral-only dosing regimen for NUZYRA in community-acquired bacterial pneumonia or “CABP”. The study is designed to demonstrate in approximately 20 CABP patients that the oral-only dosing regimen of NUZYARA will be comparable to the pharmacokinetics profile of our FDA-approved IV-followed by oral dosing regimen in patients with CABP. The Company anticipates a submission and potential approval for this posology in time for the 2020 influenza-pneumonia season.
Under a research agreement with the U.S. Department of Defense, NUZYRA is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.
Paratek owns world-wide rights to omadacycline. Paratek has entered into a collaboration with Zai Lab (Shanghai) Co., Ltd., a biopharmaceutical company based in China, to support the development and commercialization of omadacycline for patients in Greater China.
Paratek is open to discussing partnerships for rights in other regions with interested parties. Please contact us here.
The FDA approved SEYSARA® (sarecycline) in October 2018 for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. SEYSARA is marketed by Almirall, LLC in the U.S. For complete prescribing information, including the Warnings and Precautions, please visit here.
Paratek has retained rest of world (outside of the U.S.) rights to sarecycline and is currently exploring partnership opportunities to develop and approve sarecycline in appropriate markets. Please contact us here.