Breaking News
October 18, 2018 - From Biopsy to Diagnosis
October 18, 2018 - Sexual harassment and assault linked to worse physical/mental health among midlife women
October 18, 2018 - Stumped by medical school? A Q&A with a learning specialist
October 18, 2018 - Targeting immune checkpoints in microglia could reduce out-of-control neuroinflammation
October 18, 2018 - FDA Approves Talzenna (talazoparib) for gBRCAm HER2-Negative Locally Advanced or Metastatic Breast Cancer
October 18, 2018 - Many U.S. adults confused about primary care, study shows
October 18, 2018 - With philanthropic gifts, Stanford poised to make major advances in neurosciences | News Center
October 18, 2018 - Mice study shows antibiotics are not always necessary to cure sepsis
October 18, 2018 - Researchers discover why heart contractions are weaker in individuals with HCM
October 18, 2018 - Participation in organized sport during childhood may have long-term skeletal benefits
October 18, 2018 - Probiotic/antibiotic combination could eradicate drug-resistant bacteria
October 17, 2018 - More Socioeconomic Challenges for Hispanic Women With HIV
October 17, 2018 - 49,XXXXY syndrome – Genetics Home Reference
October 17, 2018 - Scientists uncover possible new causes of Tourette syndrome
October 17, 2018 - Girl undergoes unusual heart surgery after compassionate-use exemption | News Center
October 17, 2018 - Health Issues That Are Sometimes Mistaken for Gluten Sensitivity
October 17, 2018 - Elective induction of labor at 39 weeks may be beneficial option for women and their babies
October 17, 2018 - New smart watch algorithms can accurately monitor wearers’ sleep patterns
October 17, 2018 - Researchers demonstrate epigenetic memory transmission via sperm
October 17, 2018 - FDA, DHS announce memorandum of agreement to address cybersecurity in medical devices
October 17, 2018 - Health Tip: Know the Risks of Chicken Pox
October 17, 2018 - Immunotherapy effective against hereditary melanoma
October 17, 2018 - Researchers reveal new mechanism for how animal cells stay intact | News Center
October 17, 2018 - Alzheimer's Goes Under the Cryo-Electron Microscope
October 17, 2018 - Medicare for all? CMS chief warns program has enough problems already
October 17, 2018 - Metrohm Raman introduces Mira P handheld Raman system
October 17, 2018 - Expanding the knowledge about hippocampus to better understand cognitive deficits in MS
October 17, 2018 - Study of Nigerian breast cancer patients reveals prevalence of aggressive molecular features
October 17, 2018 - Many healthy children may have metabolic risk factors, finds study
October 17, 2018 - A new antibiotic could be a better, faster treatment for tuberculosis
October 17, 2018 - “I will not become a Robot Doctor”: A medical student vows to practice compassion
October 17, 2018 - Study findings may explain sporadic outbreaks of C. difficile infections in hospitals
October 17, 2018 - Purdue researchers develop new chemical process to find better drug ‘fits’ for patients
October 17, 2018 - Yale researchers develop way to attack RNA with small-molecule drugs
October 17, 2018 - New pragmatic study launched to understand the effectiveness of new type 2 diabetes drug
October 17, 2018 - Alnylam Announces Plan to Initiate Rolling Submission of a New Drug Application and Pursue Full Approval for Givosiran
October 17, 2018 - Nine cases of polio-like illness suspected in children in illinois
October 17, 2018 - Eisai enters into agreement with Eurofarma for development and sales of lorcaserin in 17 countries
October 17, 2018 - Patients once thought incurable can benefit from high-dose radiation therapy
October 17, 2018 - Researchers awarded grant to advance testing of experimental heroin vaccine
October 17, 2018 - Researchers examine SSRI use during pregnancy and major gestational malformations
October 17, 2018 - FDA grants Rare Pediatric Disease Designation for Immusoft’s Iduronicrin genleukocel-T
October 17, 2018 - Reliable Respiratory announces acquisition of Attleboro Area Medical Equipment
October 17, 2018 - Study reveals link between childhood abuse and higher arthritis risk in adulthood
October 17, 2018 - Research shows people over 65 are not performing enough physical activity
October 17, 2018 - FDA Approves Liletta (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Five Years
October 17, 2018 - Weight gain after smoking cessation linked to increased short-term diabetes risk
October 17, 2018 - Researchers find opportunity to control salt-sensitive hypertension without exercising
October 17, 2018 - Women not warned about cancer associated with breast implants
October 17, 2018 - Metrohm offers robust handheld Raman analyzer for Defense and Security
October 17, 2018 - Modeling Non-Numerical Data in Systems Biology
October 17, 2018 - Research aims to address health disparities in African-American men
October 17, 2018 - Human and cattle decoys trap outdoor-biting mosquitoes in malaria endemic regions
October 17, 2018 - High Circulating Prolactin Level Inversely Linked to T2DM Risk
October 17, 2018 - Study finds gene variant predisposes people to both Type 2 diabetes and low body weight
October 17, 2018 - Metrohm software products make it easy to comply with ALOCA and ALCOA+ guidelines
October 17, 2018 - Network of doctors identify the cause of 31 new conditions
October 17, 2018 - Notable improvement in brain cancer survival among younger patients but not much for elderly
October 17, 2018 - Scientists shed light on roles of transcription factors, TP63 and SOX2, in squamous cell carcinoma
October 17, 2018 - Costs of Medicare Diabetes Prevention Program may be higher than expected reimbursement
October 17, 2018 - Misuse of prescription opioids or benzodiazepines associated with suicidal thoughts
October 17, 2018 - New research seeks to address sex disparities in women’s health
October 17, 2018 - C-Section Rates Have Nearly Doubled Since 2000: Study
October 17, 2018 - Talking to Your Kids About STDs
October 17, 2018 - New classification of periodontal and peri-implant diseases and conditions
October 17, 2018 - Herbert D. Kleber, Pioneer in Addiction Treatment, Dies at 84
October 17, 2018 - Health effects of smoke-filled atmosphere
October 17, 2018 - Down syndrome may hold important clues to onset of Alzheimer’s disease
October 17, 2018 - A special report on US’ aging societies
October 17, 2018 - Birth mode may have acute effects on neurodevelopment, study suggests
October 17, 2018 - Global health innovation system fails to deliver affordable treatments to patients, says report
October 17, 2018 - Simple, inexpensive test quickly detects antibiotic-resistant ‘superbugs’
October 17, 2018 - New drugs could reduce risk of heart disease when added to statins
October 17, 2018 - Visible and valued: Stanford Medicine’s first-ever LGBTQ+ Forum
October 17, 2018 - HVP vaccination not linked with rise in teen risky sex
October 17, 2018 - Potential ‘early warning markers’ for sepsis discovered
October 17, 2018 - Who knew? Life begins (again) at 65
October 17, 2018 - Application of blood pressure guidelines ups treatment
October 17, 2018 - Stanford researchers find that small molecule may help treat enzyme deficiency
October 17, 2018 - Speed Cameras Save Money and Lives in New York City
FDA Approves Nuzyra (omadacycline) for Community-Acquired Bacterial Pneumonia and Acute Skin and Skin Structure Infections

FDA Approves Nuzyra (omadacycline) for Community-Acquired Bacterial Pneumonia and Acute Skin and Skin Structure Infections

image_pdfDownload PDFimage_print

FDA Approves Nuzyra (omadacycline) for Community-Acquired Bacterial Pneumonia and Acute Skin and Skin Structure Infections

BOSTON, Oct. 02, 2018 (GLOBE NEWSWIRE) — Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK) today announced that the U.S. Food and Drug Administration (FDA) has approved Nuzyra (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI). Nuzyra, a modernized tetracycline, is a once-daily IV and oral antibiotic that exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and drug resistant strains. The Company plans on making Nuzyra available in the first quarter 2019.

“In the face of ever-increasing antibiotic resistance, the FDA approved Nuzyra with a label having full approval for both CABP and ABSSSI. We are excited to bring to physicians an effective, well-tolerated monotherapy option for patients,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer, Paratek. “Nuzyra offers clinicians the ability to treat patients with the IV and transition them home to complete treatment with the oral formulation. This potentially helps reduce hospitalizations and the costs associated with hospital stays.”

The Centers for Disease Control and Prevention (CDC) estimates that drug-resistant bacteria cause 2 million illnesses and approximately 23,000 deaths each year in the United States. The main bacteria causing CABP, Streptococcus pneumoniae, is responsible for 1.2 million infections and 7,000 deaths, whereas ABSSSI is responsible for more than 750,000 hospitalizations. The increase of antibiotic resistance continues to drive the need for new, effective therapies.

“Treating pneumonia and skin infections has become increasingly complex as existing antibiotic therapies sometimes have reduced efficacy as resistance continues to grow. This reality makes it increasingly challenging to provide safe and effective treatments to patients,” said Keith Kaye, M.D., MPH, Director of Clinical Research, Division of Infectious Diseases, University of Michigan. “There continues to be a need for novel antibiotics with both IV and oral formulations, such as Nuzyra, to help physicians stay ahead of the evolving resistance landscape.”

The approval of Nuzyra is supported by multiple clinical trials within the company’s global development program. Nearly 2,000 adult patients received Nuzyra and it was found to be efficacious and generally safe and well tolerated. As part of the approval, Paratek has agreed to conduct post marketing studies in CABP and pediatrics.

“The approval of Nuzyra is an historic milestone for Paratek as it represents 20 years of research and development of this life-saving antibiotic for patients affected by community-acquired infections,” said Michael F. Bigham, Chairman and CEO, Paratek. “There are countless champions of Nuzyra who have been tireless in their efforts to ensure its advancement to commercialization – from patients, clinicians and study investigators to our Paratek team. We are grateful to all who played a role in making Nuzyra available to patients in need. We are excited to launch Nuzyra early next year.”

About Nuzyra

Nuzyra (omadacycline) is a novel antibiotic with both once-daily intravenous (IV) and oral 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 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 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 www.fda.gov/medwatch.

Please see full Prescribing Information for Nuzyra at www.NUZYRA.com.

About Paratek Pharmaceuticals, Inc.

Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. The company’s lead commercial product, Nuzyra, is a once-daily intravenous and oral antibiotic for the treatment of adult patients with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek is also studying Nuzyra for the treatment of urinary tract infections (UTI).

Paratek is also preparing a marketing authorization application for omadacycline in the European Union. Paratek has entered into a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

Forward Looking Statements

This press release contains forward-looking statements, including statements about the development, launch and commercialization of Nuzyra, the potential for Nuzyra to treat ABSSSI, CABP, UTI and other serious community-acquired bacterial infections, the prospect of Nuzyra providing broad-spectrum activity and commercialization activities. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as “potential,” “prospective,” “prepare” and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under “Risk Factors” and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2017, and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

PARATEK® and the Hexagon Logo are registered trademarks of Paratek Pharmaceuticals, Inc. Nuzyra and its design logo are trademarks of Paratek Pharmaceuticals, Inc.

Source: Paratek Pharmaceuticals

Posted: October 2018

Related Articles:

Nuzyra (omadacycline) FDA Approval History

Tagged with:

About author

Related Articles