Innovative Therapeutics in Oncology and Neuroscience
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NUZYRA
FDA-and China NMPA-approved, Once-Daily Oral and IV Broad Spectrum Antibiotic
Addressing Antibiotic Resistance
Clinical Per-protocol Population
Investigator-assessed Clinical Response
at Post Therapy Evaluation¹
Clinical Per-protocol Population
Investigator-assessed Clinical Response
at Post Therapy Evaluation²
Approved
NDC 71715-001-01
NUZYRA
(omadacycline) for in
100 mg/vial
single-dose vial
For intravenous infusion
Dambuted by
on MA-0056
CABP
NUZYRAⓇ
(omadacycline)
150
OMC
New differentiated tetracycline
antibiotic
Clinical success in CABP (left)
and ABSSSI (right)
Category 1 Innovative Drug in
China
% of Population
ABSSSI
93%
90%
96%
94%
100
100
80
60
40
20
0
NUZYRA
(n=316/340)
MOXIFLOXACIN
(n=312/345)
Difference 95% CI, 2.5 (-1.7, 6.8)
% of Population
NA g ∞
20
80
60
40
0
NUZYRA
(n=259/269)
LINEZOLID
(n=243/260)
Difference 95% CI, 2.8 (-1.0, 6.9)
Commercial launch in December 2021; Successful NRDL inclusion for both IV and oral formulations on Jan 1st, 2024
Sources: Paratek corporate presentation, February 2021; NUZYRA Prescribing Information, Paratek Pharmaceuticals, Inc; Stets R, Popescu M, Gonong JR, et al. Omadacycline for community-acquired bacterial
pneumonia. N Engl J Med 2019;380:517-27; O'Riordan W, Green S, Overcash JS, et al. Omadacycline for acute bacterial skin and skin-structure infections. N Engl J Med 2019;380:528-38.
Notes: (1) 5-10 days after last dose; (2) 7-14 days after last dose.
Clinical Data -
Anti-infectiveView entire presentation