On October 2, 2018, the US Food and Drug Administration (FDA) approved NUZYRA™ (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSIs). NUZYRA is in a new class of antibiotics, the aminomethylcyclines, that was designed specifically to overcome bacterial resistance to tetracyclines. NUZYRA was developed as a once-daily, broad-spectrum antibiotic with intravenous and oral formulations, and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypical, and drug-resistant strains; this new agent will be available in the first quarter of 2019. Nearly 2000 adult patients were treated with NUZYRA during clinical development, and it was found to be efficacious and generally safe and well-tolerated. As part of the FDA approval, postmarketing studies with NUZYRA in CABP and pediatrics will be conducted.
The Centers for Disease Control and Prevention estimates that drug-resistant bacteria cause 2 million illnesses and approximately 23,000 deaths each year in the United States. The main bacteria causing CABP, Streptococcus pneumoniae, is responsible for 1.2 million infections and 7000 deaths, whereas ABSSSI is responsible for more than 750,000 hospitalizations. The increase in antibiotic resistance continues to drive the need for novel antibiotics with both intravenous and oral formulations to help physicians stay ahead of the evolving resistance landscape, and NUZYRA is a major step in filling that need; it not only has broad-spectrum antibiotic activity, but also has activity against drug-resistant pathogens, including methicillin-resistant Staphylococcus aureus, penicillin-resistant and multidrug-resistant S pneumoniae, vancomycin-resistant Enterococcus, and extended-spectrum beta-lactamase–producing Enterobacteriaceae.
Source: Paratek announces FDA approval of NUZYRA™ (Omadacycline) [news release]. Boston, MA: Paratek Pharmaceuticals; October 2, 2018. http://investor.paratekpharm.com/phoenix.zhtml?c=253770&p=irol-newsArticle&cat=news&id=2369985. Accessed October 4, 2018.