EPA-0627 - Safety profile of methylphenidate hydrochloride-modified release (MPH-LA) in adults and children with attention deficit hyperactivity disorder

Abstract

The safety profile of MPH-LA in the paediatric population has been well studied. However, there are very limited studies reporting safety of MPH-LA in adults. We present the safety profile of MPH-LA in adults and from a pooled analysis in children. Data from 3 multiple-dose, double-blind, placebo-controlled studies of 7-12 weeks duration in children with ADHD; MPH-LA (10-80mg/d) (n=314) & placebo (n=318) (aged 6-12 yrs in 2 studies &13-17 yrs in one study) were pooled for this analysis. In addition, data from 722 adult patients, 18-60 yrs of age with ADHD receiving MPH-LA 40-80 mg/d (n=542) or placebo (n=180) from double-blind dose confirmation phase of 9-week duration from one study was included in the analysis. Common adverse events (AEs) reported by both adult and paediatric ADHD patients were decreased appetite, headache, nasopharyngitis, nausea, and insomnia (Table). Incidence of serious AEs (SAEs) was low with MPH-LA in both adults (0.7%) and children (0.6%) compared with placebo group (1.1% in adults and 0.3% in children). Our findings show that safety profile of MPH-LA in adults is similar to that observed in the paediatric population. Table Adverse events (>5%) by preferred term in multiple dose, placebo-controlled studies In adult and paedlatrlc ADHD patients Adults Children Most common AEs MPH-LA N=542, n (%) Placebo N=1B0, n (%) MPH-LA N=314, n (%) Placebo N=31S, n (%) Total number of patients with anyAE 401 (74.0) 108 (60.0) 132 (42.0) 112(35.2) Y Decreased appetite 136(25.1) 8 (4.4) 30(9.6) 5(1.6) Y Headache 111 (20.5) 30 (16.7) 37 (11.8) 32 (10.1) Y Dry mouth 110(20.3) 4(2.2) 0 0 Y Nausea 58 (10.7) 9(5.0) 12 (3.8) 4 (1.3) Y Nasopharyngitis 54 (10.0) 17(9.4) 13(4.1) 15 (4.7) Y Insomnia 44 (8.1) 7(3.9) 8 (2.5) 4(1.3) Y Hyperhidrosis 43(7.9) 5(2.8) 0 0 Y Palpitations 39(7.2) 1 (0.6) 0 0 Y Fatigue 38(7.0) 11 (6.1) 5(1.6) 4(1.3) Y Dizziness 32 (5.9) 5(2.8) 5(16) 1 (0.3) Y Irritability 32(5.9) 8 (4.4) 4(1.3) 1 (0.3) Y Anxiety 29(5.4) 1 (0.6) 3(1.0) 0 Y Initial insomnia 28(5.2) 2(1.1) 5(1.6) 5(1.6) Analysis data set: Safety population of double-blind dose confirmation phase of 9-week duration conducted in adult ADHD patients and pooled safety population from 3 paediatric studies.