Judy Pm van Stralen1. 1. JPM van Stralen Medicine Professional Corporation, Ottawa, Ontario.
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.
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 ADHDpatients 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: M A González; H S Pentikis; N Anderl; M F Benedict; H H DeCory; S J Hirshey Dirksen; S J Hatch Journal: Int J Clin Pharmacol Ther Date: 2002-04 Impact factor: 1.366
Authors: James Swanson; Suneel Gupta; Andrew Lam; Ira Shoulson; Marc Lerner; Nishit Modi; Elizabeth Lindemulder; Sharon Wigal Journal: Arch Gen Psychiatry Date: 2003-02