Last update 04 Nov 2024

Moxifloxacin Hydrochloride

Last update 04 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-((4as,7as)-octahydro-6H-pyrrolo(3,4-b)pyridin-6-yl)-4-oxo-3-quinolinecarboxylic acid, MFLX, Moxifloxacin

+ [26]

Target

Bacterial DNA gyrase x Topoisomerase IV

Mechanism

Bacterial DNA gyrase inhibitors, Topoisomerase IV inhibitors

Therapeutic Areas

Infectious DiseasesEye DiseasesMouth and Tooth Diseases+ [5]

Active Indication

Complicated intra-abdominal infectionBlepharitisConjunctivitis+ [19]

Inactive Indication

AbscessAcute sinusitisComplicated skin and skin structure infection+ [14]

Originator Organization

Bayer AG

Active Organization

Bayer Yakuhin Ltd.

Fresenius Kabi USA LLC

Bayer AG

+ [6]

Inactive Organization

Bayer HealthCare Pharmaceuticals, Inc.Alcon Laboratories, Inc.

Bayer HealthCare AG

+ [4]

Drug Highest PhaseApproved

First Approval Date

US (10 Dec 1999),

Acute bacterial sinusitisBronchitis, ChronicCommunity Acquired Pneumonia

RegulationOrphan Drug (US), Priority Review (CN)

Structure

Molecular FormulaC21H25ClFN3O4

InChIKeyIDIIJJHBXUESQI-DFIJPDEKSA-N

CAS Registry186826-86-8

413

Clinical Trials associated with Moxifloxacin Hydrochloride

NCT03244072 / Not yet recruitingPhase 2/3

Safety and Efficacy of Intracameral Zimoxin (0.1% Moxifloxacin Solution) for Prevention of Endophthalmitis After Cataract Surgery

Intracameral injection of 0.1% moxifloxacin solution after cataract surgery to prevent endophthalmitis

Start Date01 Jun 2025

Sponsor / Collaborator

Zion Therapeutics, LLC

NCT06253715 / Not yet recruitingPhase 3IIT

Shortened Regimen for Drug-susceptible TB in Children

While drug-susceptible tuberculosis (TB) disease in children currently requires four to six months of treatment, most children may be able to be cured with a shorter treatment of more powerful drugs. Shorter treatment may be easier for children to tolerate and finish as well as ease caregiver strain from managing treatment side effects and supporting children over many months. The primary objective of this study is to evaluate if a 2-month regimen (including isoniazid (H), rifapentine (P), pyrazinamide (Z) and moxifloxacin (M)) is as safe and effective as a 4- to 6-month regimen (isoniazid, rifampicin (R), pyrazinamide, ethambutol (E)) in curing drug-susceptible TB disease in children under 10 years old. The study is also evaluating the safety of the HPZM in children with and without HIV.

Start Date15 Nov 2024

Sponsor / Collaborator

The Johns Hopkins University

NCT06441006 / Not yet recruitingPhase 3IIT

Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis (PRISM-TB)

PRISM-TB is an international, multicenter, open-label, randomized, controlled, pragmatic, stratified medicine, treatment shortening, noninferiority Phase 3 clinical trial for fluoroquinolone-susceptible multidrug-resistant/rifampin-resistant pulmonary tuberculosis (FQ-S MDR/RR-TB).
The trial objective is to evaluate whether stratified medicine treatment strategies for FQ-S MDR/RR-TB, defined by a pre-specified risk stratification algorithm, have noninferior efficacy to a one-size-fits-all control regimen (the local standard-of-care [SOC] regimen consistent with preferred regimen(s) in international guidelines), as measured by TB-related unfavorable outcomes at Week 73.

Start Date01 Nov 2024

Sponsor / Collaborator

The University of California, San Francisco

[+1]

100 Clinical Results associated with Moxifloxacin Hydrochloride

100 Translational Medicine associated with Moxifloxacin Hydrochloride

100 Patents (Medical) associated with Moxifloxacin Hydrochloride

6,029

Literatures (Medical) associated with Moxifloxacin Hydrochloride

01 Feb 2025·FOOD CHEMISTRY

High sensitivity distinguishing detection of fluoroquinolones with a cage-based lanthanide metal-organic framework in food

Article

Author: Jia, Lei ; Zhao, Xiaolei ; Zhao, Dan ; Zhao, Tongqian ; Xu, Jun ; Jia, Ruoqin ; Zhang, Lina ; Huang, Yuanyuan

Sensitive and selective detection of fluoroquinolones, especially from different sources, is challenging. This study reported an uncommon three-cage lanthanide metal-organic framework (1-Eu) with a Eu³⁺ cluster as its structural primitive using a C₂-symmetric 5,5-(Pyrazine-2,6-diyl) diisophthalic acid ligand. The 1-Eu probe effectively detected four fluoroquinolones through distinct color changes and spectral emission bands, demonstrating excellent performance with low detection limits: moxifloxacin (LOD: 9.3 nM), danofloxacin (LOD: 33.7 nM), gatifloxacin (LOD: 67.9 nM), and ofloxacin (LOD: 238.6 nM). Mechanistic studies revealed that internal filtration and photoinduced electron transfer (a-PET) effects were key factors. Furthermore, 1-Eu was successfully used to detect fluoroquinolones in food samples. Additionally, portable paper-based sensors were developed to quickly semi-quantify analyte concentrations using a smartphone color recognition app, underscoring the practical potential of this probe. This study introduces a novel methodology for the identification and detection of fluoroquinolones to enhance food safety.

01 Feb 2025·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

Enhancement of sensitivity for moxifloxacin spectrofluorimetric analysis through photoinduced electron transfer inhibition. Green assessment with application to pharmaceutical eye drops

Article

Author: Attia, Tamer Z. ; Omar, Mahmoud A. ; Mohamed, Abobakr A. ; El-Deen, Deena A M Nour ; Mohamed, Abobakr A ; El-Deen, Deena A.M. Nour ; Abbas, Asmaa Mohamed ; Omar, Mahmoud A ; Attia, Tamer Z

A green, simple, rapid, selective, and highly sensitive fluorimetric protocol has been established for quantitative analysis of the antibacterial drug moxifloxacin in its pure form and pharmaceutical dosage form. Owing to photoinduced electron transfer, moxifloxacin exhibits low native fluorescence in neutral media. Based on that, the developed fluorimetric protocol depends on inhibiting the photoinduced electron transfer effect of the nitrogen atom presented on the pyrrolidine ring in moxifloxacin by suitable adjusting of pH of the medium surrounding it, leading to its protonation. It is simply achieved by using 0.5 M acetic acid. This protonation enhances the native fluorescence of moxifloxacin, turning it into a stronger one. This fluorescence was measured at 498 nm after excitation at 295 nm with a linearity range from 10 to 60 ng mL^-1 and a high correlation coefficient value of 0.9998. The fluorimetric approach could be applied for moxifloxacin detection with a limit of 0.89 ng mL^-1 and a quantification limit of 2.69 ng mL^-1. The developed method has been validated according to ICH guidelines, indicating high accuracy and excellent precision. Furthermore, the developed fluorimetric protocol was applied successfully for moxifloxacin analysis in pharmaceutical eye drops. As a result, the proposed protocol could be easily applied for quality control of moxifloxacin in different laboratories all over the world.

01 Jan 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

An LC MS/MS method for the simultaneous determination of ten antimicrobials and its application in critically ill patients

Article

Author: Li, Hongxia ; Zhao, Jing ; Zhu, Ping ; Liu, Bing ; Zhang, Guanxuanzi ; Chen, Xiaomin ; Wang, Fang ; Lu, Qian ; Liu, Tingting

Significant pharmacokinetic variation occurs in critically ill patients, leading to underexposure to antibiotics and poor prognosis. In this study, we developed a simple, sensitive, and fast liquid chromatography tandem mass spectrometry (LCMS/MS) platform for the simultaneous quantification of 8 antibacterial and 2 antifungal drugs, which is optimally suited for clinically efficient, real-time therapeutic drug monitoring (TDM). Multiple reaction monitoring (MRM) mass spectrometry was used in this method, and samples were prepared via protein precipitation with methanol. Chromatographic separation was accomplished on a BGIU Column-U02 (2.1ｘ50 mm, 3 µm), with six stable isotopes and one analog as an internal standard. The overall turnaround time of the assay was 5 minutes. All the drugs tested (piperacillin, cefoperazone, meropenem, levofloxacin, moxifloxacin, daptomycin, linezolid, vancomycin, fluconazole and voriconazole) were linear in the test concentration range (r ≥ 0.9900), the accuracy was 95 %-111 %, the precision variation coefficient was greater than or equal to 10 %, the lower limit of quantitation was 0.31-7.51 mg/L, and the coefficient of variation of the matrix factor was less than 10 %. The recovery rates ranged from 85 % to 115 %, and the antibiotics were stable at 4°C and -20°C for 6 days, with an offset of greater than or equal to 15 %. This method was successfully applied to routine TDM in 252 elderly critically ill patients.

News (Medical) associated with Moxifloxacin Hydrochloride

14 Oct 2024

·www.globenewswire.com

Paratek Pharmaceuticals Announces Presentation of Several New Studies of NUZYRA® (omadacycline) Across a Range of Serious Infections at IDWeek 2024

-- Highlights include data from clinical, non-clinical and microbiology programs, real-world patient use and a five-year microbiologic surveillance study of NUZYRA BOSTON, Oct. 14, 2024 (GLOBE NEWSWIRE) -- 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, announces that data from several new studies of NUZYRA® (omadacycline) will be presented at IDWeek 2024, Oct. 16-19 at the Los Angeles Convention Center in Los Angeles, CA. “We continue to invest in science as part of our continued commitment to furthering the medical community’s understanding of NUZYRA’s potential utility across a broad range of serious, community-acquired infections, including pulmonary and skin infections,” said Randy Brenner, chief development and regulatory officer of Paratek. “Notably, researchers will share the interim safety results of an open-label, non-inferiority trial of NUZYRA in the treatment of bone and joint infections as well as data from a real-world study assessing both clinical and microbiological outcomes of treatment with NUZYRA for pulmonary Mycobacterium abscessus complex, a rare pulmonary disease that Paratek is also evaluating in a Phase 2 study.” Oral Presentations Abstract title: Improving Traditional Registrational Trial Endpoints: Development and Application of a Desirability of Outcome Ranking (DOOR) Endpoint for Acute Bacterial Skin and Skin-Structure InfectionsSession: Breaking Ground: ID Clinical TrialsPresenter: Jessica Renee Howard-Anderson, M.D., M.Sc. (Independent research)Session Date, Time: Thursday, Oct. 17; 10:30 a.m. - 11:45 a.m. (PT) Session Location: 404 ABSubmission ID: 1828901 Abstract title: Evaluation of Fecal Pharmacokinetics and Metagenomic Changes Following the Administration of Intravenous Omadacycline to Healthy SubjectsSession: Hot Topics in Microbiome SciencePresenter: Kevin Garey, Pharm.D. (Investigator-initiated research)Session Date, Time: Friday, Oct. 18; 3:15 p.m. - 4:30 p.m. (PT)Session Location: 411Submission ID: 1828708 Abstract title: Clinical and Microbiological Outcomes of Omadacycline for Pulmonary Mycobacterium Abscessus Complex Session: TB and Nontuberculous Mycobacteria UpdatesPresenter: Mohammed Al Musawa, Pharm.D., BCIDP (Investigator-initiated research)Session Date, Time: Saturday, Oct. 19; 3:15 p.m. - 4:30 p.m. (PT) Session Location: 403 ASubmission ID: 1828690 Poster Sessions Poster title: Safety of Omadacycline Versus Standard-of-Care Oral Antibiotic Treatment for Bone and Joint Infections: Interim Results from an Open-Label, Non-Inferiority, Randomized Controlled Trial Poster Session Title: Bone and JointPresenter: Amy Y. Kang, Pharm.D., BCIDP (Investigator-initiated research)Date, Time: Thursday, Oct. 17; 12:15 p.m. - 1:30 p.m. (PT) Location: Hall J & KSubmission ID: 1828407 Rapid Fire and Poster title: Activity of Omadacycline Against 35,000 Bacterial Clinical Isolates and Resistant Organism Subsets from Patients in the United States (2019–2023)Poster session: HAIs: SurveillancePresenter: Michael Huband, B.S. (Paratek research)Date, Time: Thursday, Oct. 17, 2024; 12:15 p.m. - 1:30 p.m. (PT)Location: Hall J & KSubmission ID: 1817385 Poster title: In Vitro Activity of Omadacycline and Comparator Agents against a Collection of Neisseria Gonorrhoeae Urine Isolates Collected from the United States During 2018-2020 Poster session: Treatment of Antimicrobial Resistant InfectionsPresenter: S.J. Ryan Arends, Ph.D. (Paratek research)Date, Time: Friday, Oct. 18; 12:15 p.m. - 1:30 p.m. (PT)Location: Hall J & KSubmission ID: 1829425 Poster title: Current Prescribing Practices and Guideline Concordance for the Treatment of Community-Acquired Bacterial Pneumonia (CABP) across Outpatient and Urgent Care Visits Poster session: Antibiotic Stewardship: Non-Inpatient SettingsPresenter: Tomefa Asempa, Pharm.D. (Investigator-initiated research)Date, Time: Saturday, Oct. 19, 12:15 p.m. - 1:30 p.m. (PT)Location: Hall J & KSubmission ID: 1827423 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 for 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 an antibiotic with both once-daily oral and intravenous (IV) formulations indicated for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible microorganisms. A next generation 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

Phase 2License out/inDrug ApprovalClinical Result

31 Jul 2024

·www.globenewswire.com

Paratek Pharmaceuticals Completes Five-Year Microbiologic Surveillance Study of NUZYRA® (omadacycline) Demonstrating No Change in In Vitro Potency Against Indicated Pathogens

- No Emergence of Resistance was Observed- Additional Years of Surveillance are Under Way BOSTON, July 31, 2024 (GLOBE NEWSWIRE) -- 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

Drug ApprovalLicense out/inPhase 2Clinical Result

23 Jul 2024

·pmlive.com

Paratek announces positive late-stage results for Nuzyra in bacterial pneumonia

Paratek Pharmaceuticals has announced positive late-stage results for its lead commercial candidate, Nuzyra (omadacycline), to treat patients with moderate-to-severe community-acquired bacterial pneumonia (CABP). The phase 3 double-blind Omadacycline for Pneumonia Treatment in the Community-2 (OPTIC-2) study has been comparing the efficacy and safety of once-daily intravenous (IV)-to-oral Nuzyra to IV-to-oral moxifloxacin, an antibiotic used to treat certain infections caused by bacteria, including pneumonia, skin and abdominal infections, in 670 adult patients with moderate-to-severe CABP. Infecting over 900,000 people in the US every year, bacterial pneumonia is caused by various bacteria. The most common form, Streptococcus pneumoniae, occurs when the body is weakened and the bacteria protrudes into the lungs. Already approved for CABP by the US Food and Drug Administration (FDA), Nuzyra is a novel antibiotic that is designed to overcome tetracycline resistance and exhibits activity across a variety of bacteria to treat CABP and acute bacterial skin and skin structure infections. The trial met both the FDA-specified primary and secondary endpoints after Nuzyra achieved statistical non-inferiority (NI) in the intent-to-treat (ITT) population compared to moxifloxacin, achieving high rates of clinical success with early clinical response timepoint rates of 89.6%, compared to 87.7% for moxifloxacin, respectively. In addition, Nyzyra achieved NI versus moxifloxacin at the post-treatment evaluation visit, five to ten days after the completion of therapy in both the ITT (86% for Nuzyra and 87.7% for moxifloxacin) and the clinically evaluable population (94.1% for Nuzyra versus 95.9% for moxifloxacin), with safety and tolerability consistent with prior studies and the current FDA prescribing information for Nuzyra. Commenting on the results, Randy Brenner, chief development and regulatory officer, Paratek, said: “This study provides additional data confirming Nuzyra as an effective and well-tolerated treatment option for CABP.” “Our clinical study database is the largest clinical trial dataset in pneumonia across all antibiotics approved by the FDA in the last decade… [and] we intend to submit the study report to the FDA and engage in label update negotiations later this year,” Brenner added. Additionally, a phase 2b study of Nuzyra is already being conducted to evaluate the antibiotic in non-tuberculous mycobacterial pulmonary disease, a rare disease caused by Mycobacterium abscessus.

Phase 3Clinical ResultPhase 2Drug ApprovalQualified Infectious Disease Product

100 Deals associated with Moxifloxacin Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00874	Moxifloxacin Hydrochloride	J01MA14 S01AE07	DB00218

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Plague	US	Bayer HealthCare Pharmaceuticals, Inc.	27 Sep 2016
Complicated intra-abdominal infection	US	Fresenius Kabi USA LLC	03 Apr 2015
Blepharitis	JP	Novartis Pharma AG	26 Jul 2006
Conjunctivitis	JP	Novartis Pharma AG	26 Jul 2006
Corneal Ulcer	JP	Novartis Pharma AG	26 Jul 2006
Dacryocystitis	JP	Novartis Pharma AG	26 Jul 2006
Hordeolum	JP	Novartis Pharma AG	26 Jul 2006
Abscess	US	Bayer HealthCare Pharmaceuticals, Inc.	22 Nov 2005
Non-complicated skin and skin structure infection	US	Bayer HealthCare Pharmaceuticals, Inc.	22 Nov 2005
Acute Bronchitis	JP	Bayer Yakuhin Ltd.	11 Oct 2005
Bacterial Infections	JP	Bayer Yakuhin Ltd.	11 Oct 2005
Pharyngolaryngitis	JP	Bayer Yakuhin Ltd.	11 Oct 2005
Pneumonia	JP	Bayer Yakuhin Ltd.	11 Oct 2005
respiratory tract; infection, chronic	JP	Bayer Yakuhin Ltd.	11 Oct 2005
Secondary infection	JP	Bayer Yakuhin Ltd.	11 Oct 2005
Sinusitis	JP	Bayer Yakuhin Ltd.	11 Oct 2005
Skin and skin structure infections	JP	Bayer Yakuhin Ltd.	11 Oct 2005
Tonsillitis	JP	Bayer Yakuhin Ltd.	11 Oct 2005
Complicated skin and skin structure infection	US	Bayer HealthCare Pharmaceuticals, Inc.	13 Jun 2005
Conjunctivitis, Bacterial	US	Harrow, Inc.	15 Apr 2003

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Tuberculosis, Multidrug-Resistant	Phase 3	BR	Global Alliance for TB Drug Development	30 Jul 2018
Tuberculosis, Multidrug-Resistant	Phase 3	GE	Global Alliance for TB Drug Development	30 Jul 2018
Tuberculosis, Multidrug-Resistant	Phase 3	MY	Global Alliance for TB Drug Development	30 Jul 2018
Tuberculosis, Multidrug-Resistant	Phase 3	PH	Global Alliance for TB Drug Development	30 Jul 2018
Tuberculosis, Multidrug-Resistant	Phase 3	RU	Global Alliance for TB Drug Development	30 Jul 2018
Tuberculosis, Multidrug-Resistant	Phase 3	ZA	Global Alliance for TB Drug Development	30 Jul 2018
Tuberculosis, Multidrug-Resistant	Phase 3	TZ	Global Alliance for TB Drug Development	30 Jul 2018
Tuberculosis, Multidrug-Resistant	Phase 3	UG	Global Alliance for TB Drug Development	30 Jul 2018
Multidrug resistant pulmonary tuberculosis	Phase 3	GE	Global Alliance for TB Drug Development	01 Feb 2015
Multidrug resistant pulmonary tuberculosis	Phase 3	KE	Global Alliance for TB Drug Development	01 Feb 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04179500 (PaSEM, CTgov)	Phase 2	Multidrug resistant pulmonary tuberculosis \| Tuberculosis, Multidrug-Resistant	26	BPaMZ	motshtmvox(dqveudzkgw) = wwlopdmptx oippguzjwd (srtudakuzk, phqkqwpwnw - ajnbeqjmfi) View more	-	19 Sep 2024
NCT02589782 (TB-PRACTECAL, Pubmed) Manual	Phase 2/3	Extensively Drug-Resistant Tuberculosis	552	standard care	gbqrplaubi(jpbsodjzkz) = phxpxetwia ydhhbptmhb (jztwcovxbv ) View more	Positive	01 Feb 2024
				BPaLM(bedaquiline + pretomanid + linezolid+ moxifloxacin )	gbqrplaubi(jpbsodjzkz) = hkgbplfoak ydhhbptmhb (jztwcovxbv ) View more
NCT03338621 (CTgov)	Phase 2/3	Multidrug resistant pulmonary tuberculosis \| Tuberculosis, Multidrug-Resistant	455	ethambutol+rifampicin+isoniazid+pyrazinamide (Drug Sensitive-TB 2HRZE/4HR)	ipkjqiuuvu(zaqoiakoyj) = jwqibroyau nvaibufkwn (sguipeampa, cspiiclnpu - nfvngbnbcl) View more	-	08 Nov 2023
				4BPaMZ (Drug Sensitive-TB 4BPaMZ)	ipkjqiuuvu(zaqoiakoyj) = ghzwogtubp nvaibufkwn (sguipeampa, hotvpxupjz - bxqcualzla) View more
ERS2022	Not Applicable	-	-	Moxifloxacin	vknblhtuhz(eigvwooail) = arqgvvbthu iihoqqnehv (okrivarzvf )	-	04 Sep 2022
				Silver nanoparticles	vknblhtuhz(eigvwooail) = cbxvfzmcus iihoqqnehv (okrivarzvf )
S31/A5349 (Pubmed)	Phase 3	Pulmonary Tuberculosis	-	Rifapentine-moxifloxacin regimen	gngtchttsq(uhpfhyckah): absolute difference in unfavorable outcomes = -7.4 (95% CI, -20.8 to 6.0)	Positive	30 Aug 2022
				Control regimen
Pubmed Manual	Not Applicable	Pulmonary Tuberculosis	77	optimized background regimen+Moxifloxacin	cdtfgkueyz(istrrwqsqw) = knunnfdroa mzcwcfsysg (jqmjmhhfnh ) View more	Positive	04 May 2022
				optimized background regimen+Bedaquiline	cdtfgkueyz(istrrwqsqw) = xbzrkzelds mzcwcfsysg (jqmjmhhfnh ) View more
ARVO2022	Not Applicable	-	-	Moxifloxacin	uiyhlvbslu(zqygafuyna) = jqbxdsuwbu orypbfqcfl (xxnpvnbqjp )	-	01 May 2022
				Antibiotic use	uiyhlvbslu(zqygafuyna) = fsqixnwyaw orypbfqcfl (xxnpvnbqjp )
ARVO2022	Not Applicable	Lacerations	-	Moxifloxacin NPs	ektjivwmib(zqcjrnmoqs) = biqgvvgipw zsqtsmsckl (oobdwdxcmw ) View more	-	01 May 2022
				Moxifloxacin	ojnpgmzbnb(vqhbsnzesk) = agbwsshnns qagwlmhzvn (mrxwegytyq )
NCT02410772 (S31/A5349, CTgov)	Phase 3	Pulmonary Tuberculosis	2,516	ethambutol+rifampin+Pyridoxine (vitamin B6)+isoniazid+pyrazinamide (Regimen 1 (2HRZE/4HR))	juisgsbmrp(retfhxiodn) = ilswkslosv kpupioxlrj (nstmbgpftk, brxyngfmyv - jpcvmrkhgx) View more	-	28 Sep 2021
				ethambutol+Rifapentine+rifampin+Pyridoxine (vitamin B6)+isoniazid+pyrazinamide (Regimen 2 (2HPZ/2HP))	juisgsbmrp(retfhxiodn) = qcpswwnmua kpupioxlrj (nstmbgpftk, eefargqmcn - pdnkmnivjd) View more
NCT02410772 (Study 31, Pubmed \| Br Dent J)	Phase 3	Tuberculosis	2,516	4-month rifapentine-based regimen with moxifloxacin	tpgktkmjsy(xpnttdaxpj) = cccjqbwlff mpbjoqblke (gelylzenkj )	Positive	06 May 2021
				4-month rifapentine-based regimen without moxifloxacin	tpgktkmjsy(xpnttdaxpj) = uvikntgosn mpbjoqblke (gelylzenkj )

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