The Food and Drug Administration (FDA) has granted Orphan Drug designation to omadacycline for the treatment of infections caused by nontuberculous mycobacteria, including nontuberculous mycobacteria pulmonary disease caused by Mycobacterium abscessus complex (MABc).
Nontuberculous mycobacteria (NTM) pulmonary disease caused by MABc affects approximately 11,500 patients in the United States and is commonly treated with a combination of several antibiotics, most of which are intravenous. Omadacycline, an aminomethylcycline antibiotic, is specifically designed to overcome tetracycline resistance and has broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria, and other drug-resistant strains.
The Company is evaluating the efficacy, safety and tolerability of oral omadacycline in approximately 75 adults with NTM pulmonary disease caused by MABc in an ongoing phase 2b study (ClinicalTrials.gov Identifier: NCT04922554). Patients will be randomly assigned to receive either omadacycline 300mg orally once daily or placebo. The primary endpoints are improvements in symptoms and safety and tolerability following 12 weeks of treatment.
Omadacycline is marketed under the brand name Nuzyra for the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.
The FDA’s Orphan Drug designation is granted to medicines intended to treat or prevent rare diseases or disorders that affect fewer than 200,000 individuals.
Paratek Pharmaceuticals announces FDA Orphan Drug designation for Nuzyra® (omadacycline) for the treatment of infections caused by nontuberculous mycobacteria. News release. Paratek Pharmaceuticals, Inc. Accessed August 19, 2021. https://www.globenewswire.com/news-release/2021/08/18/2283087/33636/en/Paratek-Pharmaceuticals-Announces-FDA-Orphan-Drug-Designation-for-NUZYRA-omadacycline-for-the-Treatment-of-Infections-Caused-by-Nontuberculous-Mycobacteria.html.