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Methylphenidate Regulatory History Pediatric Advisory Committee Meeting June 30, 2005

Methylphenidate Regulatory History Pediatric Advisory Committee Meeting June 30, 2005. Paul J. Andreason, M.D. Team Leader Division of Neurpharmacological Drug Products. Approved Medical Treatment Modalities. Stimulants Methylphenidate Products Amphetamine Products Pemoline Atomoxetine.

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Methylphenidate Regulatory History Pediatric Advisory Committee Meeting June 30, 2005

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  1. Methylphenidate Regulatory HistoryPediatric Advisory Committee Meeting June 30, 2005 Paul J. Andreason, M.D.Team Leader Division of Neurpharmacological Drug Products

  2. Approved Medical Treatment Modalities • Stimulants • Methylphenidate Products • Amphetamine Products • Pemoline • Atomoxetine

  3. Methylphenidate and ADHD over time • NDA 10-187 Ritalin Tablets (methylphenidate HCl) December 5, 1955 “Minimal Brain Dysfunction” • 1962 Congress amended the Food Drug & Cosmetic Act to require that a drug demonstrate effectiveness prior to its approval

  4. Formulation Changes • Extended Release • 18-029 Ritalin SR (methylphenidate HCL) Sustained-Release Tablets 3/30/1982 • 21-121 Concerta (methylphenidate HCL) Extended-Release Tablets 8/11/200021-259Metadate CD (methylphenidate HCL) Extended-Release Capsules4/3/2001 • 21-284 Ritalin LA (methylphenidate HCL) Extended-Release Capsules 6/5/2002 • 21-802 Focalin XR (dex-methylphenidate) Extended Release Capsules 5/26/ 2005

  5. Formulation Changes • Solutions • 21-419 Methylin (methylphenidate HCL) Oral Solution 12/19/2002 • Chewable Tablets • 21-475 Methylin (methylphenidate HCL) Chewable Tablets 4/15/2003

  6. Drug Substance Changes • Stereo-specific • 21-278 Focalin (dexmethylphenidate HCL) Tablets 11/13/2001 • 21-802 Focalin XR (dexmethylphenidate HCL) Extended Release Capsules 5/26/ 2005

  7. Basis for Approval • Established Diagnosis of ADHD • Improvement on Class Room Measures of Attention and Behavior in Double Blinded Randomized Placebo Controlled Trials • *Swanson, Kotkin, Agler, M-Fynn and Pelham (SKAMP) laboratory school rating scale • Inattention/Overactivity with Aggression (IOWA) Conners scale.

  8. Studies Uniformly Positive

  9. SKAMP SCORES • Attention Index • Getting started • Sticking to task • Attending to an activity • Making activity transitions • Completing assigned tasks • Performing work accurately • Being neat and careful while writing and drawing • Deportment index • Interacting with other children • Interacting with adults • Remaining quite • Staying seated • Complying with teachers directions • Following classroom rules

  10. Duration of Action Claim Tested throughout the day

  11. Conclusion • Stimulants are a very reliable mainstay in the treatment of ADHD • Duration of action claims are based on significant success at multiple critical time-points • Clinical benefit must always be weighed against adverse events • Given the now broader background of the prescribing population-adverse events associated with stimulant treatment need to be labeled as accurately as possible

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