SPARLON modafinil Tablets CIV

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SPARLON (modafinil) Tablets C-IV

• Psychopharmacologic Drugs Advisory Committee
• 23 March 2006

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Back ups shown
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ADHD symptoms in withdrawal phase Teacher
observations (School ADHD-RS-IV)
Mean (SEM) scorechange from baseline
Study 310 only
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Figure 1 Changes from Baseline to Each Time
Point and Endpoint for the Total Scores from the
ADHD Rating Scale-IV (School Version)
Placebo-Controlled Studies
Andrew E Stein Awaiting data, Excel or Origin
graph
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Oxidative Metabolism
Di-alkyl-sulfone metabolite
Modafinil
valdecoxib
sulfamethizole 4-sulfonyl Aniline
Aryl-Sulfonamide
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Physicochemical and Pharmacological Properties of
Modafinil Suggest Low Potential for Abuse

• Low water solubility (incompatible with i.v.
  injection)
• Unstable at high temperatures (incompatible with
  smoking)
• Structurally unrelated to known addictive agents
  of abuse
• Lack of activation of reward centers at
  pharmacological active dosages
• Does not cause release of dopamine in vitro or in
  vivo
• Results from non-clinical abuse liability studies
  consistent with low abuse potential
• Post marketing surveilance continues to support
  the conclusion that the abuse liability of
  modafinil, if it exists, is low