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.

Cethromycin
Cethromycin1.svg
Clinical data
Routes of
administration
Oral
ATC code
  • none
Legal status
Legal status
Pharmacokinetic data
BioavailabilityBetween 35.8 and 60% in animal studies.
MetabolismLiver
Elimination half-life1.6, 3.0, 4.5, 5.9 and 6 hours. Mouse, Monkey, Rat, Dog and Human respectively.
Excretion7.0% urine 87.2% faeces
Identifiers
CAS Number
PubChem CID
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
Chemical and physical data
FormulaC42H59N3O10
Molar mass765.931 g/mol g·mol−1
3D model (JSmol)
Melting point211 to 213 °C (412 to 415 °F)
 ☒N☑Y (what is this?)  (verify)

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, 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]

ReferencesEdit

  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 Archived April 20, 2008, at the Wayback Machine
  7. ^ Cethromycin New Drug Application
  8. ^ Cethromycin New Drug Application accepted for filing by FDA[permanent dead link]
  9. ^ Advanced Life Sciences Holdings, Inc. "Complete Response Letter for Restanza NDA". Drugs.com. Retrieved 2014-03-26.

Further readingEdit