 BOSTON, Aug. 18, 2021 GLOBE NEWSWIRE -- Paratek Pharmaceuticals, Inc. Nasdaq: PRTK, a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the U.S. Food and Drug Administration FDA has granted the company orphan drug designation for NUZYRA omadacycline for the treatment of infections caused by Nontuberculous Mycobacteria NTM. This orphan drug designation includes NTM pulmonary disease caused by Mycobacterium abscessus complex MABc, which is the focus of an ongoing Phase 2b study initiated by Paratek. The FDAs Office of Orphan Drug Products grants orphan status to drugs and biologics that demonstrate promise for the treatment of diseases or conditions affecting fewer than 200,000 people in the United States. Orphan drug designation provides Paratek with certain development incentives, including tax credits for qualified clinical testing, exemptions from certain FDA application fees, and potential market exclusivity, if approved. The orphan drug designation is an important regulatory milestone that further validates our efforts to investigate the utility of NUZYRA, a once-daily, broad-spectrum antibiotic currently approved for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia, as a potential therapy option for patients afflicted with M. abscessus pulmonary disease, an orphan disease for which there are no approved therapies, said Randy Brenner, Chief Development and Regulatory Officer of Paratek. Earlier this year, we initiated our Phase 2b clinical study that is designed to examine the efficacy and safety of NUZYRA in patients with M. abscessus pulmonary disease. These clinical data will continue to build upon the expanding data and publications about NUZYRA and its potential utility in NTM abscessus. About NTM Abscessus Pulmonary infections caused by M. abscessus, an orphan disease with no FDA-approved antibiotic therapies, affects approximately 11,500 patients in the United States. Patients with pulmonary disease caused by M. abscessus have a myriad of symptoms including severe fatigue, fever, cough, and shortness of breath. The standard of care typically involves a combination of multiple antibiotics, most of which are intravenous, which can often require life-long treatment that is complicated by long-term tolerability challenges and multiple adverse events. About the Phase 2b NTM Study The Phase 2b study is a placebo-controlled, randomized monotherapy study of NUZYRA in patients with M. abscessus pulmonary disease who are in the early treatment phase and are not receiving other antibiotic treatments. The U.S.-based study will enroll approximately 75 subjects, randomized in a 1.5 to 1 ratio. The primary study endpoints are improvement in symptoms and safety and tolerability following 12 weeks of treatment. Due to the small numbers of patients with this orphan disease, Paratek expects the study will take about two years to complete enrollment. More information can be found at clinicaltrials.gov under the study ID number NCT04922554. About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use. The companys lead commercial product, NUZYRA omadacycline, is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. 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. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights. Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA sarecycline, a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC Almirall. Paratek retains the development and commercialization rights for sarecycline in the rest of the world. In 2019, Paratek was awarded a contract from BARDA, valued at 285 million, to support the development and U.S.-based manufacturing of NUZYRA for the treatment of pulmonary anthrax. For more information, visit or follow ParatekPharma on Twitter. About NUZYRA NUZYRA omadacycline is a novel once-daily antibiotic with both 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. Indications and Usage NUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms: Community-Acquired Bacterial Pneumonia CABP caused by the following: Streptococcus pneumoniae, Staphylococcus aureus methicillin-susceptible isolates, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae. Acute Bacterial Skin and Skin Structure Infections ABSSSI caused by the following: Staphylococcus aureus methicillin-susceptible and -resistant isolates, Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. includes S. anginosus, S. intermedius, and S. constellatus, Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Important Safety Information Contraindications 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 andor 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 eight 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 eight 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 of 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 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. To report SUSPECTED ADVERSE REACTIONS, contact Paratek Pharmaceuticals, Inc. at 1-833-727-2835 or FDA at 1-800-FDA-1088 or Please see full Prescribing Information for NUZYRA at Forward Looking Statements This press release contains forward-looking statements related to our overall strategy, products, prospects 