Paratek Pharmaceuticals, Inc., a biopharmaceutical company focused
on providing innovative medical therapies that create positive
patient stories in the hospital, community and public health
settings, today shared overall findings from the company’s
five-year post-approval microbiologic surveillance study of NUZYRA®
(omadacycline), its broad-spectrum, oral and IV antibiotic.
Surveillance studies are required by U.S. Food and Drug
Administration (FDA) for all antibiotics as post-approval
commitments and are intended to monitor for minimum inhibitory
concentration (MIC) shifts as an indicator of potential resistance
development.
The surveillance study, timed to the market introduction of
NUZYRA in early 2019, was designed to monitor the in vitro activity
of omadacycline and relevant standard-of-care comparator
antibiotics against Gram-positive and Gram-negative clinical
bacterial isolates recovered from patients in the United States
with different infection types. In addition, the program was
designed to track the potential emergence of resistance to
omadacycline as well as monitor the susceptibility patterns of
comparator drugs.
A total of 35,000 clinical isolates collected between 2019 and
2023 were evaluated. Omadacycline demonstrated consistent in vitro
potency against the isolates evaluated with no emergence of
resistance reported (i.e. MIC values remained unchanged with no
year-on-year increases).
“Since its commercial introduction in 2019 and its increased use
across the United States, these in vitro results further support
that NUZYRA remains an effective treatment option against the
different bacterial pathogens that cause community-acquired
bacterial pneumonia and acute bacterial skin and skin structure
infections, for which NUZYRA is indicated to treat,” said Randy
Brenner, chief development and regulatory officer of Paratek.
“Although this post-approval commitment with the FDA is complete,
we have elected to extend this important microbiologic surveillance
program for additional years, as part of Paratek’s continued
commitment to address antimicrobial resistance.”
The five-year study was conducted by JMI Laboratories in
collaboration with Paratek. The results from this study will be
presented and published later this year and have been submitted to
the FDA, thus completing the post-approval commitment.
The data are publicly available at paratek-keystone.com or can
be requested via the AMR register on Vivli at
vivli.org/amr-data-register/.
The microbiologic surveillance study was funded as part of the
company's Project BioShield contract (75A50120C00001) with the
Biomedical Advanced Research and Development Authority (BARDA),
part of the Administration for Strategic Preparedness and Response
within the U.S. Department of Health and Human Services.
About Paratek Pharmaceuticals, Inc. Paratek
Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical
company focused on providing innovative medical therapies that
create positive patient stories in the hospital, community and
public health settings.
The company's lead commercial product, NUZYRA® (omadacycline),
is a once-daily oral and intravenous antibiotic available in the
United States for the treatment of adults with community-acquired
bacterial pneumonia (CABP) and acute bacterial skin and skin
structure infections (ABSSSI). Paratek has a collaboration
agreement with Zai Lab Limited for the development and
commercialization of omadacycline in the greater China region and
retains all remaining global rights. Zai Lab received approval of
both IV and oral NUZYRA as a Category 1 innovative drug by the
National Medical Products Administration of China for the treatment
of CABP and ABSSSI in December 2021 and in Macao for the treatment
of CABP and ABSSSI in May 2023.
Paratek is also conducting a Phase 2b study with NUZYRA in a
rare disease, non-tuberculous mycobacterial (NTM) pulmonary
disease, caused by Mycobacterium abscessus complex.
In December 2019, BARDA awarded Paratek a contract
(75A50120C00001) that is now valued at up to approximately $304
million. In addition to supporting the development of NUZYRA for
both the treatment and prophylaxis of pulmonary anthrax, this
contract supports the U.S. onshoring of NUZYRA and manufacturing
security requirements; FDA post-marketing requirements associated
with the initial NUZYRA approval; and the procurement of up to
10,000 treatment courses of NUZYRA for the treatment of
anthrax.
For more information, visit www.ParatekPharma.com or follow
us on LinkedIn and Twitter.
About NUZYRA®NUZYRA® (omadacycline) is a novel
antibiotic with both once-daily oral and intravenous (IV)
formulations for the treatment of community-acquired bacterial
pneumonia (CABP) and acute bacterial skin and skin structure
infections (ABSSSI). A modernized tetracycline, NUZYRA is
specifically designed to overcome tetracycline resistance and
exhibits activity across a spectrum of bacteria, including
Gram-positive, Gram-negative, atypicals and other drug-resistant
strains.
IMPORTANT SAFETY
INFORMATIONCONTRAINDICATIONSNUZYRA is
contraindicated in patients with known hypersensitivity to
omadacycline or tetracycline-class antibacterial drugs, or to any
of the excipients.
WARNINGS AND PRECAUTIONSMortality imbalance was
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. The cause of the
mortality imbalance has not been established. All deaths, in both
treatment arms, occurred in patients > 65 years of age; most
patients had multiple comorbidities. The causes of death varied and
included worsening and/or complications of infection and underlying
conditions. Closely monitor clinical response to therapy in CABP
patients, particularly in those at higher risk for mortality.
The use of NUZYRA during tooth development (last half of
pregnancy, infancy and childhood to the age of 8 years) may cause
permanent discoloration of the teeth (yellow-gray-brown) and enamel
hypoplasia. The use of NUZYRA during the second and third trimester
of pregnancy, infancy and childhood up to the age of 8 years may
cause reversible inhibition of bone growth.
Hypersensitivity reactions have been reported with NUZYRA.
Life-threatening hypersensitivity (anaphylactic) reactions have
been reported with other tetracycline-class antibacterial drugs.
NUZYRA is structurally similar to other tetracycline-class
antibacterial drugs and is contraindicated in patients with known
hypersensitivity to tetracycline-class antibacterial drugs.
Discontinue NUZYRA if an allergic reaction occurs.
Clostridium difficile associated diarrhea (CDAD) has been
reported with use of nearly all antibacterial agents and may range
in severity from mild diarrhea to fatal colitis. Evaluate if
diarrhea occurs.
NUZYRA is structurally similar to tetracycline-class
antibacterial drugs and may have similar adverse reactions. Adverse
reactions, including photosensitivity, pseudotumor cerebri, and
anti-anabolic action (which has led to increased BUN, azotemia,
acidosis, hyperphosphatemia, pancreatitis, and abnormal liver
function tests), have been reported for other tetracycline-class
antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA
if any of these adverse reactions are suspected.
Prescribing NUZYRA in the absence of a proven or strongly
suspected bacterial infection is unlikely to provide benefit to the
patient and increases the risk of the development of drug-resistant
bacteria.
ADVERSE REACTIONSThe most common adverse
reactions (incidence ≥2%) are nausea, vomiting, infusion site
reactions, alanine aminotransferase increased, aspartate
aminotransferase increased, gamma-glutamyl transferase increased,
hypertension, headache, diarrhea, insomnia, and constipation.
DRUG INTERACTIONSPatients who are on
anticoagulant therapy may require downward adjustment of their
anticoagulant dosage while taking NUZYRA. Absorption of
tetracyclines, including NUZYRA is impaired by antacids containing
aluminum, calcium, or magnesium, bismuth subsalicylate and iron
containing preparations.
USE IN SPECIFIC POPULATIONSLactation:
Breastfeeding is not recommended during treatment with NUZYRA.
See full prescribing information here.
MEDIA CONTACT: Christine Fanelle Scient PR
Christine@ScientPR.com215-595-5211