Summary of Cancellation for Cefditoren pivoxil (*Spectracef)

The purpose of this New Drug Submission–New Active Substance (NDS-NAS) was to seek market authorization for Spectracef (cefditoren pivoxil) for the oral treatment in adults and adolescents (12 years of age and older) of the following mild-to-moderate infections when caused by susceptible strains of the designated microorganisms:

• Acute bacterial exacerbation of chronic bronchitis caused by Haemophilus influenzae (including β-lactamase-producing strains), Haemophilus parainfluenzae (including β-lactamase-producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), or Moraxella catarrhalis (including β-lactamase-producing strains).

• Community-acquired pneumonia caused by Haemophilus influenzae (including β-lactamase-producing strains), Haemophilus parainfluenzae (including β-lactamase-producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), or Moraxella catarrhalis (including β-lactamase-producing strains).

• Pharyngitis/tonsilitis caused by Streptococcus pyogenes.

• Acute sinusitis caused by Streptococcus pneumoniae, Streptococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.

• Uncomplicated skin and skin-structure infections caused by Staphylococcus aureus (including β-lactamase-producing strains) or Streptococcus pyogenes.

Due to the recommendation to issue a Notice of Deficiency (NOD), Health Canada has not authorized indications for this product.

The sponsor submitted drug quality, non-clinical, comparative bioavailability, and clinical data as well as post-marketing safety data. The nine pivotal Phase 3 clinical safety and efficacy data consisted of the following: Study ME303 (for acute bacterial exacerbation of chronic bronchitis); Studies CEF 97-002 and CEF 97-006 (for community-acquired pneumonia); Studies CEF 97-008 and CEF 97-010 (for pharyngitis/tonsilitis); Studies CEF 97-004 and CEF 97-007 (for acute sinusitis); and Studies CEF 97-009 and CEF 97-011 (for uncomplicated skin and skin-structure infections).

At the time of the cancellation, the review of the submission was ongoing for most review components. Health Canada had identified major deficiencies and data gaps in the drug quality data that would have precluded conducting a meaningful quality assessment and hence issuing an approval. The submission review had not started for the drug quality component, but focused only on the initial scoping. A Notice of Deficiency (NOD) was recommended for this submission insofar as chemistry and manufacturing were concerned. The sponsor chose to cancel their submission in order to re-file at a later date with additional data.

There is no expected impact for patients using SAP or in clinical trials. There are no clinical trials underway in Canada for the use of Spectracef.

Requests for special access to Spectracef will be considered on a case-by-case basis. For more information about the Special Access Programme refer to the programme’s web site: http://www.healthcanada.gc.ca/sap or http://www.santecanada.gc.ca/pas.