1 One Year Post Exclusivity Adverse Event Review: Sumatriptan Pediatric Advisory Committee Meeting November 18, 2005 Susan McCune, M.D. Medical Officer.

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Presentation transcript:

1 One Year Post Exclusivity Adverse Event Review: Sumatriptan Pediatric Advisory Committee Meeting November 18, 2005 Susan McCune, M.D. Medical Officer Division of Pediatric Drug Development Center for Drug Evaluation and Research Food and Drug Administration

2 Background Drug Information Drug: Imitrex ® (sumatriptan) nasal spray Therapeutic Category: Selective 5-hydroxytryptamine receptor agonist Sponsor: GlaxoSmithKline Indication: Acute treatment of migraine attacks with or without aura in adults. Not recommended for use in patients under 18 years of age. Original Market Approval: August 26, 1997 Pediatric Exclusivity Granted: February 18, 2004

3 Sumatriptan Nasal Spray Pediatric Information Added to the Label: –Two controlled clinical trials (12-17 year old patients, N=1248) –Adverse events were similar to those reported for adults –Studies did not establish efficacy compared to placebo Pediatric patients accounted for less than 5% (3,104-3,468 prescriptions) of all paid prescription claims for Imitrex ® nasal spray from 3/02 to 2/05. 1 Six unduplicated pediatric adverse event reports identified during the one-year post-exclusivity period: –None of the reports were serious or life-threatening 1 Caremark Dimension Rx™, Mar Feb 2005, Data extracted Mar 23, 2005

4 No new concerning unlabeled safety signals identified in pediatric adverse events reported through AERS in the one-year post-exclusivity period. This completes the one-year post- exclusivity AE reporting as mandated by BPCA. FDA recommends routine monitoring of AEs for sumatriptan in all populations. Does the Advisory Committee concur? Summary: Sumatriptan Nasal Spray

5 Acknowledgements ODS Mark Avigan Gerald Dal Pan Michael Evans Sonny Saini OND Eric Bastings Lana Chen Susan McDermott