INDICATION

Aptensio XR® (methylphenidate HCl extended-release) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

For US Healthcare Professionals

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Aptensio XR, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.

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12-HOUR DURATION

Study 1: Once-daily Aptensio XR delivered significant results from hour 1 to hour 121

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At all evaluated time points, SKAMP total scores were significantly better (lower) for Aptensio XR versus placebo (P≤0.0261)1,2

Improvements in SKAMP total scores versus placebo1

Clinical Studies - SKAMP Clinical Studies - SKAMP
  • Aptensio XR® (methylphenidate HCl extended-release) demonstrated statistical significance at all time points tested post dose: 1, 2, 3, 4.5, 6, 7.5, 9, 10.5, and 12 hours1
About SKAMP total score

The Swanson, Kotkin, Agler, M-Flynn, Pelham (SKAMP) Scale is a validated, 13-item classroom assessment tool that is used to assess ADHD symptoms.The SKAMP total score is an average of all 13 item scores.

  • Difficulty starting classroom assignments
  • Difficulty staying on task for the allotted time
  • Difficulty attending to an activity or discussion of the class
  • Difficulty stopping and making a transition to the next period
  • Problems interacting with peers in the classroom
  • Problems interacting with school staff
  • Difficulty remaining quiet according to classroom rules
  • Difficulty staying seated according to classroom rules
  • Problems completing assigned work
  • Problems performing work accurately
  • Difficulty being careful or neat while writing or drawing
  • Problems complying with teacher's requests or directions
  • Problems following established classroom rules
Lower SKAMP scores represent an improvement in ADHD symptoms.1,3

Aptensio XR has proven efficacy, with safety data for up to 2 years1

The efficacy and safety of Aptensio XR were established in a phase III, randomized, double-blind, placebo-controlled, flexible-dose, crossover study using a standardized 12-hour ADHD evaluation in a simulated classroom setting.1

Study 1: Conducted with children aged 6 to 12 years who met DSM-IV-TR criteria for ADHD (N=26)1

Clinical Study Clinical Study

With an optional 21-month extension phase, some patients continued therapy for up to 2 years.1

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IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Aptensio XR, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.