General Information

Nuzyra (omadacycline) is a modernized tetracycline, specifically designed to overcome tetracycline resistance.

Nuzyra is specifically indicated for the following:

Adult patients with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.

Adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae.

Nuzyra is supplied as a solution for intravenous administration and as tablets for oral administration.

Side Effects

Adverse reactions associated with the use of Nuzyra may include, but are not limited to, the following:

nausea

vomiting

infusion site reactions

alanine aminotransferase increased

aspartate aminotransferase increased

gamma-glutamyl transferase increased

hypertension

headache

diarrhea

insomnia

constipation

Clinical Trial Results

The FDA approval of Nuzyra was based on the following studies:

Community-Acquired Bacterial Pneumonia

A total of 774 adults with CABP were randomized in a multinational, double-blind, double-dummy trial comparing Nuzyra to moxifloxacin. Nuzyra was administered 100-mg intravenously every 12 hours for two doses on Day 1, followed by 100-mg intravenously daily, or 300mg orally, daily. Moxifloxacin 400-mg was administered intravenously or orally daily. Total treatment duration was 7-14 days. Omadacycline met the FDA-specified primary endpoint of statistical non-inferiority in the intent-to-treat population compared to moxifloxacin at the early clinical response (ECR) 72-120 hours after initiation of therapy. The ECR rates for the omadacycline and moxifloxacin treatment arms were 81.1 % and 82.7%, respectively.

Acute Bacterial Skin and Skin Structure Infections

A total of 1,390 adults with ABSSSI were randomized in two multicenter, multinational, double-blind, double-dummy trials (Trial 2 and Trial 3). Both trials compared 7 to 14 days of Nuzyra to linezolid. Patients with cellulitis, major abscess, or wound infection were enrolled in the trials. In Trial 2, patients were randomized to Nuzyra (100-mg intravenously every 12 hours for 2 doses followed by 100-mg intravenously every 24 hours, with the option to switch to 300-mg orally every 24 hours) or patients were randomized to linezolid (600-mg intravenously every 12 hours, with the option to switch to 600-mg orally every 12 hours). In Trial 3, patients were randomized to Nuzyra (450-mg oral once a day on Days 1 and 2, followed by 300-mg orally once a day) or patients were randomized to linezolid (600-mg orally every 12 hours). In both trials, efficacy was determined by the successful early clinical response at 48 to 72 hours after the first dose in the mITT population and was defined as a 20% or greater decrease in lesion size. In Trial 2 clinical response was reached by 84.8% of the Nuzyra arm and 85.5% of the linezolid arm. In Trial 3 clinical response was reached by 87.3% of the Nuzyra arm and 82.2% of the linezolid arm.