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• W2338355451 abstract "Objective: Examine treatment effectiveness between equivalent doses of non-OROS methylphenidate ER and OROS (unique extended release delivery system) methylphenidate ER among a clinical sample of youth with Attention-Deficit/Hyperactivity Disorder (ADHD).Background: In November 2014, the FDA announced concerns regarding the therapeutic equivalence of non-OROS methylphenidate ER (generics manufactured by Mallinckrodt and Kremers) as compared to OROS methylphenidate ER (brand name Concerta, generic manufactured by Actavis). Anecdotal caregiver reports corroborate this claim.Methods: As part of routine clinical care, some patients taking generic methylphenidate ER continued to demonstrate significant symptoms of ADHD. Contact with patient pharmacies revealed that the non-OROS formulation had been dispensed. Patients were then instructed to fill their prescription at a pharmacy that supplied OROS at the same dosage. The Conners-Third Edition:Parent Rating Scale-Short Form was used to compare ADHD symptoms when patients were taking non-OROS versus OROS at follow up visits. A repeated measures mixed-model approach was used to compare treatment effectiveness.Results: For the entire sample (N=14), there was a reduction in the mean score on the Inattention Scale from clinically significant (T-score>65) to not clinically significant (T-score<65) when patients were changed from non-OROS to OROS (mean T-score reduction=23, p<.0001). When stratified by ADHD subtype, patients with Combined Type (mean T-score reduction=21, p=.0015) and Predominantly Inattentive Type (mean T-score reduction=27, p=.0141) demonstrated a similar reduction in T-scores on the Inattention Scale when they were changed from non-OROS to OROS. Patients with Combined Type demonstrated a similar reduction on the Hyperactivity/Impulsivity Scale when they were changed from non-OROS to OROS (mean T-score reduction=21, p=.0048).Conclusions: Results provide empirical support for FDA concerns that non-OROS is not therapeutically equivalent to OROS for the treatment of ADHD. This is important information for neurologists who care for youth with ADHD and something to consider when other long-acting medications go generic. Disclosure: Dr. Lally has nothing to disclose. Dr. Kral has nothing to disclose. Dr. Boan has nothing to disclose." @default.
• W2338355451 created "2016-06-24" @default.
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• W2338355451 date "2016-04-05" @default.
• W2338355451 modified "2023-09-27" @default.
• W2338355451 title "Not All Generic Concerta Is Created Equal: Comparison of OROS versus Non-OROS Methylphenidate ER for the Treatment of ADHD (P6.331)" @default.
• W2338355451 hasPublicationYear "2016" @default.
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