User:T.nguyen05/sandbox
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| Clinical data | |
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| Trade names | Sivextro |
| Routes of administration | Oral,IV |
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| Pharmacokinetic data | |
| Bioavailability | 91% |
| Protein binding | 70-90% |
| Elimination half-life | 12 hours |
| Excretion | Feces |
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| Formula | C17H15FN6O3 |
| Molar mass | 370.338 g/mol g·mol−1 |
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Tedizolid (formerly torezolid[1]), marketed under the trade name Sivextro, is an oxazolidinone drug being developed by Cubist Pharmaceuticals following acquisition of Trius Therapeutics (originator: Dong-A Pharmaceuticals) for complicated skin and skin-structure infections (cSSSI), including those caused by methicillin-resistant Staphylococcus aureus (MRSA).[2]
The prodrug tedizolid is called "TR-701", while the active moiety is called "TR-700".[3][4]
Clinical trials
[edit]Tedizolid proved its non-inferiority to linezolid in two phase III trials, Establish 1 and Establish 2.[5] Both trials compare a six-day regimen of tedizolid 200 mg once-daily against a ten-day regimen of linezolid 600 mg twice-daily.
On June 20, 2014, tedizolid was approved by the Food and Drug Administration (FDA) for the treatment of ABSSSI.[6] It can be taken both orally and given via IV injection.[7] Sivextro is the second treatment approved by the FDA under the new federal Generating Antibiotic Incentives Now law, known as the GAIN Act. That law gives drug makers priority review and an additional five years of market exclusivity in order to spur the development of new antibiotics to fight the rise of drug-resistant “superbugs.”
Adverse effects
[edit]The most common adverse effects found in the clinical trials include nausea, headache, diarrhea, vomiting, and dizziness.[8] Phase I studies of tedizolid found a possible dose and duration effect on hematologic parameters beyond 6 days of treatment.[8] Its safety in patients with decreased levels of white blood cells has not been established, and thus, alternative treatments should be considered.[6] Patients on tedizolid are also at low risk of peripheral and optic neuropathy, similar to other members of the oxazolidinone class.[8]
References
[edit]- ^ "Trius grows as lead antibiotic moves forward". 31 Oct 2011.
- ^ "Trius Completes Enrollment In Phase 2 Clinical Trial Evaluating Torezolid (TR-701) In Patients With Complicated Skin And Skin Structure Infections". Jan 2009.
- ^ PMID 19528279 In vitro activity of TR-700, the active ingredient of the antibacterial prodrug TR-701, a novel oxazolidinone antibacterial agent.
- ^ PMID 19218276 TR-700 in vitro activity against and resistance mutation frequencies among Gram-positive pathogens.
- ^ "Cubist announces publication of pivotal data from Sivextro" Accessed October 29, 2014
- ^ a b "FDA Approval" Accessed October 29, 2014
- ^ Weisman, Robert (June 20, 2014). "FDA approves new Cubist antibiotic". Boston Globe.
- ^ a b c "Prescribing Information" Accessed October 29, 2014
Category:Oxazolidinone antibiotics Category:Tetrazoles Category:Pyridines Category:Organofluorides
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