MSD (known as Merck & Co., Inc. in the US and Canada) has announced the availability in the UK of Sivextro® (tedizolid phosphate) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. Available in both intravenous (I.V.) and oral formulations, it is the first new treatment in the oxazolidinone class of antibiotics since 2001.i Tedizolid phosphate is another option in the fight against the growing challenge of global antimicrobial resistance (AMR), which is a key topic on the agenda of the G7 summit of world leaders, taking place on June 7-8 2015, in Schloss Elmau, Germany.ii

Cases of skin infections caused by MRSA (methicillin-resistant staphylococcus aureus) in the community and MSSA (methicillin-sensitive staphylococcus aureus) are rising in the UKiii, iv with up to 25% of MRSA infections being resistant to treatment.v Recent research from the Department of Health notes that AMR costs the European Union (EU) at least €1.5 billion per year and claims an estimated 25,000 lives every year - an estimated 3,000 deaths in the UK.vi A government-commissioned AMR Review Team (chaired by economist Jim O'Neill) has projected this to increase to 390,000 deaths per annum by 2050 in Europe and globally from an estimated 700,000 to in excess of 10 million.vii

Derek Butler, Chair, MRSA Action UK, said: "I hope that this will be the start of things to come. We need pharmaceutical companies, governments, those providing healthcare and the public to all play their part in using these new treatments wisely. However, there is still a way to go to bring about the change in a culture that has relied too heavily on these golden bullets."

"Antimicrobial resistance is one of the biggest threats facing human kind - if we lose the use of antibiotics then we will put medical science back 100 years, and what we now take for granted will be confined to the history books."

About Sivextro® (tedizolid phosphate)

Tedizolid phosphate is an antibiotic approved to treat adult acute bacterial skin and skin structure infections (ABSSSI), including those caused by methicillin-resistant staphylococcus aureus (MRSA). Tedizolid phosphate has a mode of action which metabolises in the blood stream and inhibits protein biosynthesis in the bacterial cell. Tedizolid phosphate has the following features:

  • Administered once daily, it offers an effective, short (six-day) course of therapy
  • It is an oxazolidinone with in vitro activity against clinically significant susceptible Gram- positive pathogens, including MRSA
  • Available in both intravenous (I.V.) and oral formulations - providing healthcare professionals options for use either in an in-patient or out-patient setting

Please refer to the Patient information Leaflet (PIL) for tedizolid phosphate for full information available at: https://www.medicines.org.uk/emc/PIL.30320.latest.pdf and the Summary of Product Characteristics (SPC) can be found at: https://www.medicines.org.uk/emc/medicine/30319

Tedizolid phosphate was approved by the U.S. Food and Drug Administration (FDA) in June 2014 and received a marketing authorisation from the European Commission on 23rd March 2015.

Approximately 22.4% of patients treated with tedizolid phosphate in Phase 3 clinical studies (n=662) experienced at least one treatment-emergent adverse reaction. The most frequently reported adverse reactions occurring in patients receiving tedizolid phosphate in the pooled controlled Phase III clinical studies (tedizolid phosphate 200 mg once daily for 6 days) were nausea (6.9%), headache (3.5%), diarrhoea (3.2%) and vomiting (2.3%), and were generally mild to moderate in severity.

Sivextro® (tedizolid phosphate) is a registered trademark of Cubist Pharmaceuticals, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.