FDA approves new antibiotic omadacycline

According to the US Centers for Disease Control and Prevention, every year about 2 million people in the United States develop an antibiotic-resistant infection; such infections kill at least 23,000 people a year. Streptococcus pneumoniae is responsible for 1.2 million infections and 7,000 deaths.

"Treatment of pneumonia and skin infections is becoming increasingly difficult as existing antibiotics lose their effectiveness as resistance continues to grow. This reality makes it increasingly challenging to provide safe and effective patient care,” said Keith Kay, MD, Director of Clinical Research, Division of Infectious Diseases, University of Michigan, Ann Arbor.

The US Food and Drug Administration (FDA) approved a new antibiotic Omadacycline in October 2018 for the treatment of adults with community-acquired bacterial pneumonia with an acute skin infection. Read more about the drug in the article estet-portal.

New antibiotic Omadacycline in the fight against resistance

Omadacycline is a modernized broad-spectrum tetracycline designed to overcome tetracycline resistance and belongs to the tetracycline (aminomethylicline) subclass.

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•    It is approved for the treatment of pneumonia caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae and Chlamydophila pneumoniae.

•    It is also approved for the treatment of acute bacterial skin infection caused by Staphylococcus aureus, Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius and S. constellatus), Enterococcus faecalis, Enterobacter cloacae and Klebsiella pneumoniae.

In three global studies involving approximately 2000 adults, omadacycline met the requirements and was generally safe and well tolerated.

Using the new antibiotic Omadacycline

Omadacycline is available in intravenous and oral formulations, offering clinicians the option to start treatment in a healthcare facility and continue at the outpatient level.
Omadacycline will be available in the first quarter of 2019.

This is the first oral antibiotic approved for the treatment of both pneumonia and acute bacterial skin infection in nearly 20 years.

450 mg orally once a day300 mg orally once a day 

Infectious disease	Initial therapy (1 day)	Maintenance dose
pneumonia	200 mg IV over 60 minutes or 100 mg IV over 30 minutes twice	100 mg IV over 30 minutes once a day or 300 mg orally once a day
acute bacterial infection of the skin	200 mg IV over 60 minutes or 100 mg IV over 30 minutes twice	100 mg IV over 30 minutes once a day or 300 mg orally once a day
acute bacterial skin infection (outpatient treatment)

Duration of therapy – 7-14 days.

Peculiarities of using the new antibiotic – things to remember

Contraindications:

hypersensitivity to omadacycline, an antibacterial of the tetracycline class.

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Adverse reactions of Omadacycline use:

•    discoloration of the teeth and enamel hypoplasia when using the drug during tooth development (last half of pregnancy, infancy and childhood up to 8 years);

•    reversible inhibition of bone growth when used in the second and third trimester of pregnancy, infancy and childhood up to 8 years;

•    diarrhea associated with Clostridium difficile.

•    The most common adverse reactions (incidence ≥2%) are nausea, vomiting, increased alanine aminotransferase, increased aspartate aminotransferase, increased gamma-glutamyltransferase, hypertension, headache, diarrhoea, insomnia and constipation.

1.    Patients on anticoagulant therapy may require a reduction in the dose of anticoagulants.

2.    absorption of tetracyclines is impaired by antacids containing aluminium, calcium or magnesium, bismuth subsalicylate and preparations containing iron.

Modern pharmacological capabilities allow us to successfully combat bacterial resistance to currently available antibiotics. One of the new antibiotics that will become available for the treatment of pneumonia and acute bacterial skin infections is Omadacycline.

You may be interested in the article on our website estet-portal.com in the section "Infectology"

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Adapted from Medscape