EPA-0627 - Safety Profile of Methylphenidate Hydrochloride-Modified Release (MPH-LA) in Adults and Children with Attention Deficit Hyperactivity Disorder

Abstract

Introduction and objectives:

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.

Methods:

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.

Results:

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).

Conclusions:

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)
YDecreased appetite	136(25.1)	8 (4.4)	30(9.6)	5(1.6)
YHeadache	111 (20.5)	30 (16.7)	37 (11.8)	32 (10.1)
YDry mouth	110(20.3)	4(2.2)	0	0
YNausea	58 (10.7)	9(5.0)	12 (3.8)	4 (1.3)
YNasopharyngitis	54 (10.0)	17(9.4)	13(4.1)	15 (4.7)
YInsomnia	44 (8.1)	7(3.9)	8 (2.5)	4(1.3)
YHyperhidrosis	43(7.9)	5(2.8)	0	0
YPalpitations	39(7.2)	1 (0.6)	0	0
YFatigue	38(7.0)	11 (6.1)	5(1.6)	4(1.3)
YDizziness	32 (5.9)	5(2.8)	5(16)	1 (0.3)
YIrritability	32(5.9)	8 (4.4)	4(1.3)	1 (0.3)
YAnxiety	29(5.4)	1 (0.6)	3(1.0)	0
YInitial 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.