title: The clinical impact of switching attention deficit hyperactivity disorder patients from OROS(®)-MPH to Novo-MPH ER-C(®): A paediatric practice review.
abstract: OBJECTIVE
  In Canada, novo-methylphenidate extended-release capsules (Novo-MPH ER-C, Novopharm Limited, Canada) was approved as being bioequivalent to a current first-line treatment for attention deficit hyperactivity disorder (ADHD), CONCERTA (OROS-MPH, Janssen Inc, Canada). The present practice review was undertaken to determine whether bioequivalence of these products translates into therapeutic equivalence.
  
  
  METHODS
  The present study was a retrospective, single-centre, observational review of consecutive paediatric ADHD patients prescribed OROS-MPH during a seven-month period.
  
  
  RESULTS
  Of the 53 patients who had been switched to the bioequivalent product, 87% destabilized and 43% indicated a shorter duration of effect. In comparison, of those who never tried the second entry medication, only 26% destabilized. Qualitative data indicated differences with regard to side effects, efficacy and duration of effect.
  
  
  CONCLUSIONS
  The present retrospective study indicated that Novo-MPH ER-C is not therapeutically equivalent to OROS-MPH. Once an individual with ADHD is effectively managed, disruption of their treatment should be avoided.
authors.affiliation: JPM van Stralen Medicine Professional Corporation, Ottawa, Ontario.
authors.forename: Judy Pm
authors.initials: JP
authors.lastname: van Stralen
keywords: Attention deficit hyperactivity disorder; Bioequivalence; Complex modified-release formulation; Methylphenidate; Pharmacokinetics, Therapeutic equivalence