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FDA granted orphan drug designation to Paratek Pharmaceuticals for NUZYRA (omadacycline), an investigational antibiotic.
Paratek Pharmaceuticals, a US-based commercial-stage biopharmaceutical company, announced on August 18th, 2021, that FDA has granted orphan drug designation (ODD) to their drug, NUZYRA (omadacycline), for the treatment for infections caused by nontuberculous mycobacteria (NTM).
NUZYRA, Paratek’s lead commercial product, is a novel once-daily antibiotic with both oral and intravenous formulations. It has been used in the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. It is designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including gram-positive, gram-negative, atypicals, and other drug-resistant strains.
Pulmonary infections caused by Mycobacterium abscessus, an orphan disease with no FDA-approved antibiotic therapies, affects approximately 11,500 patients in the United States. Symptoms include severe fatigue, fever, cough, and shortness of breath. Treatment is typically done through combinations of multiple antibiotics and can often require life-long treatment that is complicated by long-term tolerability challenges and multiple adverse events.
Paratek is currently engaged in a placebo-controlled, randomized monotherapy Phase IIb study of NUZYRA in approximately 75 patients with M. abscessus pulmonary disease who are in the early treatment phase and not receiving other antibiotic treatments. The study will measure improvement in symptoms, safety, and tolerability following 12 weeks of treatment. Due to the small numbers of patients with this orphan disease, Paratek expects the study to take approximately two years to complete enrollment.
"The orphan drug designation is an important regulatory milestone that further validates our efforts to investigate the utility of NUZYRA,” said Randy Brenner, chief development and regulatory officer at Paratek, in a company press release. "Earlier this year, we initiated our Phase [II]b clinical study that is designed to examine the efficacy and safety of NUZYRA in patients with M. abscessus pulmonary disease. These clinical data will continue to build upon the expanding data and publications about NUZYRA and its potential utility in NTM abscessus.”
Source: Paratek Pharmaceuticals