FDA Grants Orphan Drug Designation for NUZYRA (omadacycline)

Release Date: 24-Sep-2021

US FDA has allowed Paratek Pharmaceuticals the orphan drug designation for NUZYRAandreg; (omadacycline) for the treatment of Nontuberculous Mycobacteria (NTM). NUZYRAandreg; (omadacycline) is once-daily antibiotic with both oral and intravenous (IV) formulations for the treatment of adult patients of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients. It is exactly designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-negative, Gram-positive, atypicals, and other drug-resistant strains.


There is Mortality imbalance observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. Some adverse responses (incidence =2%) are alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, vomiting etc.


The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S and it also gives several benefits, like tax credits for qualified clinical trials, potential seven years of market exclusivity after approval and exemption from user fees.

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