ISSUE 1473
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The FDA has approved Aptensio XR (Rhodes), an extended-release formulation of methylphenidate hydrochloride, for treatment of attention-deficit/hyperactivity disorder (ADHD). The Aptensio XR capsules contain multilayer beads designed to provide both a rapid onset and a long duration of action. This formulation of methylphenidate has been available in Canada as Biphentin since 2006.
METHYLPHENIDATE — Methylphenidate is effective in reducing the symptoms of ADHD in both children and adults.1,2 The effects of immediate-release methylphenidate products on behavior begin within 30 minutes and last for 3-5 hours; repeat dosing at mid-day is usually required. Long-acting methylphenidate products are dosed once daily. Some generic formulations of Concerta, which has a duration of action of 10-12 hours, have been found to release the drug at a slower
... more- L Greenhill et al. Efficacy and safety of immediate-release methylphenidate treatment for preschoolers with ADHD. J Am Acad Child Adolesc Psychiatry 2006; 45:1284.
- T Epstein et al. Immediate-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults. Cochrane Database Syst Rev 2014 Sept 18; 9:CD005041.
- WE Pelham et al. Once-a-day Concerta methylphenidate versus three-times-daily methylphenidate in laboratory and natural settings. Pediatrics 2001; 107:E105.
- FDA. Methylphenidate hydrochloride extended release tablets (generic Concerta) made by Mallinckrodt and Kudco. Available at: http://www.fda.gov. Accessed July 9, 2015.
- R Maldonado. Comparison of the pharmacokinetics and clinical efficacy of new extended-release formulations of methylphenidate. Expert Opin Drug Metab Toxicol 2013; 9:1001.
- SB Wigal et al. A randomized placebo-controlled double-blind study evaluating the time course of response to methylphenidate hydrochloride extended-release capsules in children with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol 2014; 24:562.
- SB Wigal et al. Efficacy of methylphenidate hydrochloride extended-release capsules (Aptensio XR™) in children and adolescents with attention-deficit/hyperactivity disorder: a phase III, randomized, double-blind study. CNS Drugs 2015; 29:331.
- Drugs for ADHD. Med Lett Drugs Ther 2015; 57:37.

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