1 One Year Post Exclusivity Adverse Event Review: Ciprofloxacin Pediatric Subcommittee of the Anti-infective Drugs Advisory Committee Meeting June 9, 2004.

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Presentation transcript:

1 One Year Post Exclusivity Adverse Event Review: Ciprofloxacin Pediatric Subcommittee of the Anti-infective Drugs Advisory Committee Meeting June 9, 2004 J. Harry Gunkel, MD Medical Officer Division of Pediatric Drug Development Center for Drug Evaluation and Research Food and Drug Administration

2 Background Drug Information Moiety: Ciloxan ® (ciprofloxacin) Therapeutic Category: Ophthalmic anti-infective Sponsor: Alcon Laboratories, Inc. Indication: Adults and Children > 1 year (solution). Adults and Children > 2 years (ointment): treatment of bacterial conjunctivitis caused by susceptible strains of S. aureus, S. epidermidis, S. pneumoniae, S. viridans, H. flu Original Market Approval: December 31, 1990 Pediatric Exclusivity Granted: January 10, 2003

3 Drug Use Trends in Outpatient Settings: Ciprofloxacin Ophthalmic Dispensed prescriptions for Ciloxan decreased from 2.7 to 2.2 million from Feb 2003 through Jan % of prescriptions were for children yrs. 2 Pediatricians wrote 33% of prescriptions (712,000) from Feb 2003 – Jan IMS Health, National Prescription Audit Plus™, On-line, Source Year Feb 2001 – Jan 2004, Data Extracted Feb AdvancePCS™, Dimension Rx, On-line, Feb 2002 to Jan 2004

4 Drug Use Trends in Outpatient Settings: Ciprofloxacin Ophthalmic Most common indication was “ conjunctivitis, other + unspecified. ” 1 Ciloxan was the most mentioned product for this indication in children 1-16 yrs. 1 1 IMS Health, National Disease and Therapeutic Index™, CD-ROM, Source Year Feb 2001 – Jan 2004, Data Extracted Feb 2004

5 Adverse Event Reports: Ciprofloxacin Ophthalmic 01/10/03 – 02/10/04 Total number of reports, all ages: –9 reports (3 U.S.) Age not specified for 2 Pediatric reports: –No pediatric reports were submitted during this time period.

6 Comments The FDA will continue its routine monitoring of adverse events in all populations.

7 One Year Post Exclusivity Adverse Event Review: Moxifloxacin Pediatric Subcommittee of the Anti-infective Drugs Advisory Committee Meeting June 9, 2004 J. Harry Gunkel, MD Medical Officer Division of Pediatric Drug Development Center for Drug Evaluation and Research Food and Drug Administration

8 Background Drug Information Moiety: Vigamox ® (moxifloxacin) Therapeutic Category: Ophthalmic anti-infective Sponsor: Alcon Laboratories, Inc. Indication: Adults and children ≥ 1 year: Treatment of bacterial conjunctivitis caused by susceptible organisms Original Market Approval: April 15, 2003 Pediatric Exclusivity Granted: January 10, 2003

9 Drug Use Trends in Outpatient Settings: Moxifloxacin Ophthalmic 800,000 prescriptions dispensed from Apr 2003 through Jan % of prescriptions were for children 1-16 years. 2 Ophthalmologists wrote most prescriptions (50.3%) from Feb 2003 – Jan 2004, followed by pediatricians (24%). 1 Most common indication was “ conjunctivitis, other + unspecified. ” 3 Vigamox accounted for 4.6% of the mentions for that indication in children 1-16 yrs. 3 1 IMS Health, National Prescription Audit Plus™, On-line, Source Year Feb 2001 – Jan 2004, Data Extracted Feb AdvancePCS™, Dimension Rx, On-line, Feb 2002 to Jan IMS Health, National Disease and Therapeutic Index™, CD-ROM, Source Year Feb 2001 – Jan 2004, Data Extracted Feb 2004

10 Adverse Event Reports: Moxifloxacin Ophthalmic 04/15/03 – 02/10/04 Total number of reports, all ages: – 1 report (U.S.) Pediatric reports: –1 report (U.S.) –Subconjunctival hemorrhage in 6.5 year old female 24 hours after use of Vigamox. Concomitant use of Augmentin. Recovery after discontinuation of Vigamox –Subconjunctival hemorrhage is a labeled adverse event in 1-6% of patients

11 Comments 1 labeled pediatric adverse event was reported The FDA will continue its routine monitoring of adverse events in all populations.

12 Clinical Study for Exclusivity StudyDesignPopulationEndpoints Moxifloxacin vs. Ciprofloxacin Multicenter, Randomized, Double-blind Neonates Clinical Cure Day 5 Microbial Eradication Rate

13 Clinical Study for Exclusivity: Results MoxifloxacinCiprofloxacinP-Value Clinical Cure 53%61% NS (Expected vehicle rate 70%)