Moxifloxacin Hydrochloride

TB Alliance is gratified to see clear progress against tuberculosis in the latest WHO Global TB Control Report. While TB remains one of the world’s most urgent health crises, these gains reflect the dedication of researchers, ministries of health, clinicians, communities, donors, and—most importantly—people affected by TB who have helped reverse years of COVID-related backsliding. The rebound shows that progress is possible when science, partnerships, and persistence align. We are especially encouraged by advances in the treatment of drug-resistant TB (DR-TB). Countries are adopting shorter, all-oral regimens, and the growing uptake of BPaL/M regimens (bedaquiline, pretomanid, linezolid, with or without moxifloxacin) is driving better outcomes. Shorter, simpler, safer care helps people return to their lives faster, reduces stigma, supports treatment completion, and saves costs for both people with TB and health systems. As the developer of pretomanid, TB Alliance is working to ensure six-month, all-oral DR-TB regimens reach all who need them. Our broad access efforts have helped make the rollout of pretomanid and BPaL/M the fastest and most impactful introduction of a novel TB drug and regimen in the modern era. The pipeline is also strengthening. Next-generation regimens such as SPaL are in late-stage development, with NC-009 trial results to be presented at the 2025 Union World Conference on Lung Health. Together with our partners, we are building toward TB Alliance’s vision: a one-month treatment for active TB and a one-day treatment for latent TB—innovations that could fundamentally change how the world prevents and cures TB. To translate this promise into impact, sustained investment is essential across discovery, clinical development, manufacturing, regulation, and country-level adoption. That is why ongoing shortfalls in global TB funding are so concerning. COVID-related disruptions showed that breaks in services and financing can take years to undo, at the cost of lives and momentum. We must not repeat that mistake and should instead meet the funding targets agreed at the latest UN High-Level Meeting on TB. Research suggests that investment in neglected disease R&D can yield returns as high as US$405 for every dollar spent, with benefits also resonating in traditional donor economies. With political will, scientific progress, adequate and sustained funding, and the leadership of TB-affected communities, we can accelerate research, expand access, reduce suffering, and save lives. TB Alliance will continue working with governments, partners, and communities to ensure today’s advances reach everyone who needs them, and that the next wave of innovations is delivered faster, fairly, and at scale. Together, we can end TB.

Highlights include clinical data from Phase 3 studies in Community Acquired Pneumonia (CABP) and microbiologic data from a Phase 2 study in nontuberculous mycobacterial pulmonary disease (NTM-PD) caused by Mycobacterium abscessus complex (MABc), as well as additional clinical and non-clinical data from Company- and investigator-sponsored studies KING OF PRUSSIA, Pa. and BOSTON, Oct. 17, 2025 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc., a privately held pharmaceutical company focused on the development and commercialization of specialty therapies for specialists and community care providers that address public health threats and important unmet medical needs, today announced that new data from clinical studies of NUZYRA® (omadacycline) will be presented at IDWeek 2025 in Atlanta, GA, and CHEST 2025 in Chicago, IL, both meetings being held October 19-22. “The upcoming presentations at two major conferences will provide the medical community a broad window into understanding NUZYRA’s potential utility against serious, community-acquired infections,” said Randy Brenner, chief development and regulatory officer of Paratek. “At CHEST, an oral presentation will report quality-of-life outcomes from our Phase 3b OPTIC-2 study, while new microbiological results from the Company’s Phase 2 study assessing NUZYRA in NTM-PD will be featured in an oral presentation at IDWeek. We are also pleased that additional, investigator-sponsored studies will provide research findings for NUZYRA in non-respiratory infections, including the treatment of bone and joint infections.” CHEST 2025 Oral Presentation Abstract title: Health-related quality-of-life outcomes in OPTIC-2: A randomized, controlled, Phase 3b trial of omadacycline vs. moxifloxacin in community-acquired bacterial pneumoniaSession: Lung Infections: Considerations in ManagementPresenter: Holly Mallon, RRT, M.S. (Paratek research)Session Date, Time: Tuesday, Oct. 21; 1:45 p.m. - 2:30 p.m. CTSession Location: Lakeside Center Exhibit Hall Rapid Fire Area 1CSession ID: 4043(The study has been supported in whole or part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under contract number 75A50120C00001.) CHEST 2025 Poster Session Poster title: Omadacycline outcomes in community-acquired bacterial pneumonia: pooled efficacy and safety from the Phase 3 OPTIC and OPTIC-2 trialsPoster Session Title: Chest Infections Scientific Abstract Posters (F)Presenter: Alex Winans, Pharm.D. (Paratek research)Date, Time: Wednesday, Oct. 22; 10:20 a.m. - 11:05 a.m. CTLocation: Lakeside Center Exhibit Hall Poster Area 1Poster ID: 4101(The study has been supported in whole or part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under contract number 75A50120C00001.) IDWeek 2025 Oral Presentation Abstract title: Microbiological Outcomes of Oral Omadacycline Treatment in Adults with Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD) Caused by Mycobacterium abscessus complex (MABc): Results from a Phase 2, Double-blind, Randomized, Placebo-controlled, Multi-center TrialSession: TB and Beyond: Innovations in Treatment, Resistance and Real-World ReachPresenter: Reeti Khare, Ph.D., (Paratek research)Session Date, Time: Tuesday, Oct. 21; 10:30 a.m. - 11:45 a.m. ETSession Location: B207-B208Session ID: 119 IDWeek 2025 Poster Sessions Poster title: Omadacycline was Shown to Preserve the Microbiome in a Murine Model of Post-Influenza MRSA PneumoniaPoster session: Basic Science and Translational StudiesPresenter: Jessica V. Pierce, Ph.D. (Paratek research)Date, Time: Wednesday, Oct. 22; 12:15 p.m. - 1:30 p.m. ETLocation: Poster Hall B4-B5Poster ID: P-1535 Poster title: Pooled Microbiological Outcomes from the Phase 3, Randomized OPTIC and OPTIC-2 Trials of Omadacycline vs Moxifloxacin in Community-acquired Bacterial PneumoniaPoster session: Respiratory infections: Viral and BacterialPresenter: Diane M. Anastasiou, B.S. (Paratek research)Date, Time: Monday, Oct. 20; 12:15 p.m. - 1:30 p.m. ETLocation: Poster Hall B4-B5Poster ID: P-618(The study has been supported in whole or part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under contract number 75A50120C00001.) Poster title: In Vitro Activity of Omadacycline and Comparator Agents Against Periodontal PathogensPoster session: Novel AgentsPresenter: David A. Hufnagel, Ph.D. (Investigator-initiated research)Date, Time: Tuesday, Oct. 21; 12:15 p.m. - 1:30 p.m. ETLocation: Poster Hall B4-B5Poster ID: P-1182 Poster title: Susceptibility of Omadacycline in Bone and Joint Infections: Pathogen Susceptibility and Regimen Decisions from an Ongoing Randomized Controlled TrialPoster session: Bone and JointPresenter: Amy Y. Kang, Pharm.D., BCIDP (Investigator-initiated research)Date, Time: Monday, Oct. 20; 12:15 p.m. - 1:30 p.m. ETLocation: Poster Hall B4-B5Poster ID: P-78 About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a privately held pharmaceutical company providing innovative specialty therapies for specialists and community care providers, addressing public health threats and important unmet medical needs. NUZYRA (omadacycline) is a once-daily oral and intravenous antibiotic indicated for adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). XHANCE (fluticasone propionate) is a drug-device combination product indicated for chronic rhinosinusitis (CRS) with or without polyps, targeting the site of inflammation using the proprietary Exhalation Delivery System™ (EDS®). Paratek continues to diversify its portfolio to address unmet patient needs. Paratek was acquired in 2023 by B-FLEXION and Novo Holdings. 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 https://www.paratekpharma.com/ or follow us on LinkedIn and X. About NUZYRANUZYRA (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, atypical, and other drug-resistant strains. IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONS NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients. WARNINGS AND PRECAUTIONS Mortality 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. Clostridioides 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, fixed drug eruption, 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 REACTIONS The 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 INTERACTIONS Patients 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 POPULATIONS Lactation: Breastfeeding is not recommended during treatment with NUZYRA. See full prescribing information here. About XHANCEXHANCE is a drug-device combination product that uses the Exhalation Delivery System™ (also known as the EDS®) designed to deliver a topical steroid to the high and deep regions of the nasal cavity where sinuses ventilate and drain. XHANCE is approved by the U.S. Food and Drug Administration for both the treatment of chronic rhinosinusitis without nasal polyps (also called chronic sinusitis) and chronic rhinosinusitis with nasal polyps (also called nasal polyps) in patients 18 years of age or older. IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONS: Hypersensitivity to any ingredient in XHANCE.WARNINGS AND PRECAUTIONS: Local nasal adverse reactions, including epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing, can occur. Monitor patients periodically for signs of possible changes on the nasal mucosa. Avoid use in patients with recent nasal ulcerations, nasal surgery, or nasal trauma until healing has occurred.Glaucoma and cataracts may occur with long-term use. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use XHANCE long-term.Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, rash, hypotension, and bronchospasm) have been reported after administration of fluticasone propionate. Discontinue XHANCE if such reactions occur.Immunosuppression and infections can occur, including potential increased susceptibility to or worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue XHANCE slowly.Assess for decrease in bone mineral density initially and periodically thereafter. ADVERSE REACTIONS: Chronic rhinosinusitis without nasal polyps: The most common adverse reactions (incidence 3%) are epistaxis, headache, and nasopharyngitis.Chronic rhinosinusitis with nasal polyps: The most common adverse reactions (incidence 3%) are epistaxis, nasal septal ulceration, nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations, nasal congestion, acute sinusitis, nasal septal erythema, headache, and pharyngitis. DRUG INTERACTIONS: Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects. USE IN SPECIFIC POPULATIONS: Hepatic impairment. Monitor patients for signs of increased drug exposure. See full prescribing information here. MEDIA CONTACT: Adam Silversteinadam@scientpr.com