Cethromycin

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Cethromycin
Cethromycin.png
Systematic (IUPAC) name
(1S,2R,5R,7R,8R,9S,11R,13R,14R)-8-[(2S,3R,4S,6R)- 4-Dimethylamino-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-1,5,7,9,11,13- hexamethyl-9-[(E)-3-quinolin-3-ylprop-2-enoxy] -3,17-dioxa-15-azabicyclo[12.3.0]heptadecane-4,6,12,16-tetrone
Clinical data
Legal status Phase III Clinical Trials in US
Routes Oral
Pharmacokinetic data
Bioavailability Between 35.8 and 60 % in animal studies.
Metabolism Liver
Half-life 1.6, 3.0, 4.5, 5.9 and 6 hours. Mouse, Monkey, Rat, Dog and Human respectively.
Excretion 7.0% urine 87.2% faeces
Identifiers
CAS number 205110-48-1 YesY
ATC code None
PubChem CID 5282045
ChemSpider 23258189 N
UNII J0086219X6 YesY
KEGG D02391 N
Chemical data
Formula C42H59N3O10 
Mol. mass 765.931 g/mol
Physical data
Melt. point 211–213 °C (412–415 °F)
 N (what is this?)  (verify)

Cethromycin, trade name Restanza (initially known as ABT-773[1][2]) is a ketolide antibiotic undergoing research for the treatment of community acquired pneumonia (CAP)[1][3][4][5] and for the prevention of post-exposure inhalational anthrax, and was given an "orphan drug" status for this indication.[6] Originally discovered and developed by Abbott, it was acquired by Advanced Life Sciences Inc. for further development.

On October 1, 2008 Advanced Life Sciences submitted a New Drug Application (NDA) to Food and Drug Administration (FDA) for cethromycin to treat mild-to-moderate community acquired pneumonia.[7]

On December 3, 2008 Advanced Life Sciences announced that this New Drug Application has been accepted for filing by the FDA.[8]

In June 2009, the an FDA Anti-Infective Drugs Advisory Committee review found insufficient evidence for cethromycin efficacy in treatment of community acquired pneumonia, as the Phase 3 clinical trial followed standards that were updated after the clinical trial but three months prior to review. The committee did, however, find the drug safe to use.[9]

References[edit]

  1. ^ a b Lawrence LE (June 2001). "ABT-773 (Abbott Laboratories)". Current Opinion in Investigational Drugs 2 (6): 766–72. PMID 11572654. 
  2. ^ Dougherty TJ, Barrett JF (February 2001). "ABT-773: a new ketolide antibiotic". Expert Opinion on Investigational Drugs 10 (2): 343–51. doi:10.1517/13543784.10.2.343. PMID 11178346. 
  3. ^ Zhanel GG, Hisanaga T, Nichol K, Wierzbowski A, Hoban DJ (November 2003). "Ketolides: an emerging treatment for macrolide-resistant respiratory infections, focusing on S. pneumoniae". Expert Opinion on Emerging Drugs 8 (2): 297–321. doi:10.1517/14728214.8.2.297. PMID 14661991. 
  4. ^ Reinert RR (June 2004). "Clinical efficacy of ketolides in the treatment of respiratory tract infections". The Journal of Antimicrobial Chemotherapy 53 (6): 918–27. doi:10.1093/jac/dkh169. PMID 15117934. 
  5. ^ Hammerschlag MR, Sharma R (March 2008). "Use of cethromycin, a new ketolide, for treatment of community-acquired respiratory infections". Expert Opinion on Investigational Drugs 17 (3): 387–400. doi:10.1517/13543784.17.3.387. PMID 18321237. 
  6. ^ Cethromycin - Advanced Life Sciences
  7. ^ Cethromycin New Drug Application
  8. ^ Cethromycin New Drug Application accepted for filing by FDA
  9. ^ Advanced Life Sciences Holdings, Inc. "Complete Response Letter for Restanza NDA". Drugs.com. Retrieved 2014-03-26. 

Further reading[edit]