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Paratek Pharmaceuticals Announces Presentation of Several New Studies of NUZYRA® (omadacycline) Across a Range of Serious Infections at IDWeek 2024 | ||
By: GlobeNewswire - 14 Oct 2024 | Back to overview list |
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-- 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 Infections Abstract title: Evaluation of Fecal Pharmacokinetics and Metagenomic Changes Following the Administration of Intravenous Omadacycline to Healthy Subjects Abstract title: Clinical and Microbiological Outcomes of Omadacycline for Pulmonary Mycobacterium Abscessus Complex 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 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 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 title: Current Prescribing Practices and Guideline Concordance for the Treatment of Community-Acquired Bacterial Pneumonia (CABP) across Outpatient and Urgent Care Visits About Paratek Pharmaceuticals, Inc. 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® IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS 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. 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 REACTIONS DRUG INTERACTIONS USE IN SPECIFIC POPULATIONS See full prescribing information here. MEDIA CONTACT: |
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