A review of amphetamine extended release once-daily options for the management of attention-deficit hyperactivity disorder

Figures & data

Table 1. Pharmacokinetics of available extended-release once-daily amphetamine products.

Drug	Trade Name	Time to peak plasma concentration	Half life	Typical Length of Clinical Effect	Recommended Starting Dose
Mixed amphetamine salts (MAS SLI381) (dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate) [18,19]	Adderall XR	7 hours	9 hours	12 hours	5 mg
SHP465 mixed amphetamine salts (MAS) [20]	Mydayis	2 or 4 hours	<16 hours	Up to 14 hours (adolescents)	12.5 mg
d,l-amphetamine [21,22]	Dyanavel XR (tablet or liquid)	3.9 to 4.5 hours	10.4 to 12.1 hours	Up to 13 hours (adults), up to 12 hours (liquid, children)	2.5 mg
d,l-amphetamine (AMP XR-OS) [23,24]	Adzenys (ODT or liquid)	4–5 hours	9–10 hours	Up to 12 hours	6.3 mg
Dextroamphetamine sulfate [25,26]	Dexedrine Spansule	3 hours	12 hours	8 hours	5 mg
Lisdexamphetamine (prostimulant) [27,28]	Vyvanse	4 hours	8.6 to 9.5 hours	Up to 12 hours (adults)	10 mg
Dextroamphetamine [29,30]	Xelstrym Patch	9 hours (active at 2)	6.4 hours (effect up to 12)	Up to 11 hours (children)	4.5 mg/9 hours
Dextroamphetamine Sulfate [31,32]	Attentin	1.5 hours	10.2 hours	6.5 hours (children)	5 mg

Table 2. Summary table of clinical trial results for amphetamine extended release once-daily tablets.

Authors	Drug (s)	Participants	Study Type	Methods	Findings
James et al. 2001 [33]	Adderall, extended-release dextroamphetamine, and dextroamphetamine spansules	Children 6–12 years with DSM-IV defined ADHD (n = 35)	Randomized, double-blind, placebo-controlled, crossover study in research school setting	Children given Adderall XR, immediate release dextroamphetamine, dextroamphetamine Spansules, and placebo. Behavior ratings, locomotor activity measurements, and academic measures obtained over 8 week period.	Dextroamphetamine spansules less effective in morning compared to Adderall but lasted 3–6 hours longer.
Biederman et al. 2002 [34]	Adderall XR	Children 6–12 years with DSM-IV defined ADHD (n = 584)	Multicenter, randomized, double-blind parallel group, placebo-controlled trial	Participants received placebo or 10 mg, 20 mg, or 30 mg Adderall XR for 3 weeks	Conners Global Index Scales for Teachers and Parents revealed significant and dose-related improvement in morning, afternoon, and late afternoon behavior for all active treatment groups versus placebo
McCracken et al. 2003 [14]	Adderall XR	Children 6–12 years with DSM-IV defined ADHD (N = 51)	Randomized, double-blind, crossover study in analog classroom setting	Participants randomly assigned in crossover design to each of five treatment weeks, Adderall XR 10 mg, 20 mg, Adderall 10 mg, and placebo for a week	Dose-dependent improvements noted, only 20- and 30-mg doses showed continued activity at 10.5 and 12 hours for classroom behavior and math test performance versus placebo
McGough et al. 2005 [35]	Adderall XR	Children 6–12 years with DSM-IV defined ADHD (n = 568)	24-month multi-center, open label extension of two placebo-controlled studies of mixed amephetamine salts (MAS XR; Adderall XR)	Participants began treatment with MAS XR 10 mg once daily, with 10-mg weekly dose increases to optimize effectiveness (max 30 mg/d).	Significant improvement (>30%, p < 0.001) in Conners Global Index Scale-Parent Scores maintained during long-term treatment
Ambrosini et al. 2006 [36]	Mixed Amphetamine Salts Extended Release (MAS-XR)	Children 6–12 years with DSM-IV defined ADHD (N = 2968)	9-week prospective, open-label, non-comparative study at 386 sites	Participants with well-controlled ADHD received previous psychostimulant for 2 weeks and then was converted to equivalent once-daily dose of 10-, 20-, or 30-mg MAS XR	Improvement in ADHD behavior 8 and 12 h postdose during the first week of treatment and maintained ( p < 0.0001). MAS XR treatment significantly improved symptoms compared with the baseline stimulant regimen ( p < 0.0001).
Wilson et al. 2006 [37]	Adderall XR, Concerta	Adolescents with ADHD (n = 35, 19 males)	Randomized, double-blind, placebo controlled study designed to compare two extended release stimulants and placebo on ADHD neuropsychological functioning	Adolescents completed three separate assessments (5, 8, 11 pm) on three different days and medications (Concerta, Adderall XR, and Placebo)	Significant effect on impulsivity and memory with both Concerta and Adderall XR (with no significant difference in performance between Concerta and Adderall XR)
Biederman et al. 2005 [38]	Mixed amphetamine salts extended release (MAS XR)	Adults (> or = 18 years) with ADHD (n = 223)	24-month, open-label extension of a 4-week, multicenter, doubule-blind, placebo-controlled, forced-dose-escalation study	Subjects started at 20 mg/day for 1 week with titration up to 60 mg/day for optimal therapeutic effects	ADHD symptoms significantly improved for all subjects measured by change in mean ADHD Rating Scale IV total scores and was sustained up to 24 months
Wigal et al. 2005 [39]	MAS XR (Adderall XR) vs. Atomoxetine (Strattera)	Children 6–12 years with ADHD per DSM-IV (n = 215)	Randomized, double-blind, multicenter, parallel-group, forced-dose-escalation laboratory school study	Subjects randomized to 18 days of treatment with MAS XR or atomoxetine; Atomoxetine dosed in accordance with FDA labeling up to target daily dose of 1.2 mg/kg/d, MAS XR subjects received 10 mg in week 1, 20 mg in week 2, and 30 mg during week 3	Changes in mean SKAMP (Swanson, Kotkin, Agler, M-Flynn and Pelham) deportment scores significantly greater for MAS XR than for atomoxetine at each week
Spencer et al. 2006 [40]	Adderall XR	Adolescents aged 13 to 17 years (n = 258) with ADHD	4-week, randomized, multi-center, double-blind, placebo-controlled, parallel-group, forced-dose titration study	Participants randomized to 1 of 4 active treatments (MAS XR 10, 20, 30, or 40 mg/day) or placebo.	Improvement in mean ADHD-RS-IV total scores for both inattentive and hyperactive-impulsive subscales in all 4 MAS XR treatment groups compared with placebo throughout study
Biederman et al. 2006 [41]	MAS XR vs. Atomoxetine	Girls aged 6 to 12 with ADHD (n = 215)	Post hoc analysis of data from multicenter, 18-day, randomized, double-blind, parallel-group, forced dose-titration, laboratory school study of boys and girls with ADHD	Compared efficacy, tolerability, and time course of effect of increasing doses of MAS XR (10, 20, and 30 mg/day) and atomoxetine (0.5 and 1.2 mg/k/d)	18-day treatment with MAS XR more effective than atomoxetine in terms of ratings of classroom behavior, attention, and academic productivity
Weisler et al. 2006 [42]	MAS XR	Adults>or = 18 with ADHD (N = 250)	Multisite, randomized, double-blind, placebo-controlled, parallel-group, dose-escalation study	Adults given placebo or MAS XR 20, 40, or 60 mg/day for 4 weeks	Reduction of mean ADHD Rating Scale scores; adults with more severe symptoms had greater symptoms reduction with maximum osing;statistically significant (p < .05) improvements in CAARS-S-S (Conners’ Adult ADHD Rating Scale Short Version Self-Report) ADHD index scores occurred at 4- and 12-hours postdose for all MAS XR groups
Faraone et al. 2007 [43]	MAS XR (Adderall XR) vs. Atomoxetine (Strattera)	Children ages 6 to 12 with ADHD per DSM-IV criteria (n = 215)	Analysis of data from randomized, double-blind, multicenter, parallel-group, forced-dose-escalation laboratory school study	Statistical modeling used to forecast the levels of efficacy that might be observed during 8-week treatment extension	Similar pattern to Wigal et al., 2005; MAS XR expected to be more effective that Atomoxetine
Biederman et al. 2007 [44]	MAS XR and Lisdexamfetamine dimesylate (LDX)	Children 6–12 years with ADHD per DSM-IV criteria (n = 52)	Randomized, double-blind, placebo- and active-controlled crossover study in classroom environment comparing the efficacy and safety of LDX with placebo, with MAS XR included as reference arm	Open-label administration of MAS XR for 3 weeks, titrated from 10 mg/d based on clinical response, subsequently transitioned to LDX based on MAS XR optimized dose. Participants then crossed over such that each subject received 1 week of placebo, 1 week of MAS XR, and 1 week of LDX.	Subjects treated with MAS XR had significant decreases in mean SKAMP-DS scores as compared with placebo (unable to compare LDX and MAS XR)
Spencer et al. 2008 [45]	Triple-Bead Mixed Amphetamine Salts (Mydadis)	Adults ages 18 to 55 years with ADHD per DSM-IV-TR Criteria (N = 272)	7-week, randomized, double-blind, multicenter, placebo-controlled, parallel-group, dose-optimization study	Subjects randomly assigned to triple-bead MAS (12.5 mg) or placebo	Significant improvement versus placebo in ADHD-RS-IV total score change, CGI (Clinical Global Impressions Scale)-Improvement, TASS (Time-Sensitive ADHD Symptom Scale) total score at 13–16 hours post-dose, BADDS (Brown Attention-Deficit Disorder Scale) total score, all AIM-A (Adult ADHD Impact Module) domains, and ADHD-RS-IV subscales, demonstrating extended duration of efficacy and improvements in executive functioning and Quality of LIfe
Mikami et al. 2009 [46]	Extended release amphetamine salts, osmotic-release methylphenidate and routine limited medication regimen	Male (n = 19) and female (n = 16) adolescents, ages 16–19 with ADHD	Randomized, double-blind crossover study	Participants randomly assigned to either 1 day dcourse of OROS MPH followed by a 17 day course or se-AMPH ER, or the reverse sequence	Medication appears similarly effective between males and females
Stein et al. 2011 [47]	Long-acting extended-release dexmethylphenidate (ER d-MPH) versus ER mixed amphetamine salts (ER MAS)	Children and adolescents ages 9 to 17 with ADHD (n = 56)	8-week, double-blind, crossover study	Participants administered three dose conditions of ER d-MPH and ER MAS (10, 20, and 25–30 mg) sequentially from lowest dose to highest dose with a randomized week of placebo in each period. 50% started with ER d-MPH and 50% started with ER MAS	80% demonstrated reliable change on ADHD-RS-IV at the highest dose level of ER MAS compared with 79% when receiving ER d-MPH; 3% of the responders were preferential responders to only one of the stimulant formulations
Wigal et al. 2018 [48]	SHP465 vs. immediate-release MAS (MAS IR)	Adults (>or = 18) with ADHD Rating Scale, Version IV scores ≥ 24 (n = 86)	Participants randomized to MAS (50 or 75 mg), placebo, or 25 mg MASI-R in double-blind, three-period, crossover study using a simulated adult workplace environment	Following 7-day treatment period, efficacy assessed 16 h postdose using the Permanent Product Measure of Performance (PERMP) and ADHD-RS-IV scores based on clinician ratings of counselor observations using the Time Segment Rating system and participant self-report	MAS (50/75 mg) resulted in significantly improved PERMPT total scores versus placebo, no significant difference between MAS (50/75) and MAS IR
Wigal et al. 2019 [49]	SHP465 versus placebo and MAS IR	Adolescents ages 13–17 years with ADHD having ADHD rating Scale, Version IV total scores ≥ 24 (n = 84)	Randomized, 3-period, 3-treatment crossover study in laboratory classroom setting	Efficacy assessed on last day of each 7-day treatment period using PERMP, SKAMP, and participant self report	PERMP total scores favored MAS XR over placebo at all time points
Adler et al. 2020 [50]	SHP465 versus placebo	Adults ages 18–55 years with ADHD per DSM-IV-TR criteria and baseline ADHD-RS-IV scores ≥ 24 (for the dose-optimization study; Spencer et al. 2008) or ≥ 32 for the fixed-dose study (Frick et al. 2020)	Post hoc analyses of response and remission rates on data from placebo-controlled MAX-XR dose-optimization (12.5–75 mg) and fixed-dose (25–75 mg) studies	Response and remission rates analyzed in addition to potential mediating factors	MAS XR associated with greater response and remission rates at the final treatment week and/or study endpoint. Remission rates comparable when examining based on sex and age.
Mattingly et al. 2020 [51]	SHP465 versus placebo	Children ages 6–12 years with DSM-5 defined ADHDD; baseline ADHD-Rating Scale, Fifth Edition, Child, Home Version total scores (ADHD-RS-5-HV-TS) ‡28; and baseline Clinical Global Impressions-Severity scores ‡4 (n = 89)	Randomized double-blind, placebo-controlled, fixed-dose study at 27 sites	Participants received 6.25 mg SHP465 MAS once daily or placebo for 4 weeks	MAS 6.25 mg well tolerated but not superior to placebo
Frick et al. 2020 [52]	SHP465 versus placebo	Adults with ADHD-RS-IV total scores ≥ 32 (n = 405)	Double-Blind, Randomized, Forced-Dose Trial	Participants randomized to 6 weeks of SHP465 (25, 50, or 75 mg) or placebo	Significant improvement in ADHD-RSI-IV total scores for SHP465, no significant differences between SHP465 dosages
Brown et al. 2022 [53]	SHP465 versus placebo	Adults ages 18–55 years with ADHD per DSM-IV-TR criteria and baseline ADHD-RS-IV scores ≥ 24 (for the dose-optimization study; Spencer et al. 2008) or ≥ 32 for the fixed-dose study (Frick et al. 2020)	Post hoc analyses on data from placebo-controlled MAX-XR dose-optimization (12.5–75 mg) and fixed-dose (25–75 mg) studies	Treatment response assessed using Brown Attention-Deficit Disorder Scale (BADDS)	Improvement in executive function measured by BADDS response rates was 2-fold greater than MAS XR versus placebo

Table 3. Safety and tolerability [33], [35], [61–66].

Generic Name	Trade Name	Common Adverse Effects	Serious Adverse Effects
Mixed Amphetamine salts, extended release double bead system (MAS-XR) [34,36]	Adderall XR	Decreased appetite (22%), Insomnia (17%), abdominal pain (14%), vomiting (7%), headache (4%)	Emotional lability (9%), Dizziness (2%), hostility (0.8%)
SHP465 mixed amphetamine salts, extended release triple bead system (SHP465 MAS) [20]	Mydayis	Decreased appetite (22%), Insomnia (8%)	Decreased weight (5%), irritability (6%), dizziness (4%), depression (1%), seizure, hemoptysis
D,L-amphetamine extended release [22]	Dyanavel XR	Dry mouth, decreased appetite, weight loss, nausea, stomach pain (3.8%), trouble sleeping, emotional lability, increased heart rate	Epistaxis (3.8%)
Mixed amphetamine salts extended release (MAS ER) [63]	Adzenys	Decreased appetite (22%), insomnia (17%), abdominal pain (14%)	Weight loss (4%), emotional lability (9%)
Dextroamphetamine [25]	Dexedrine Spansule	Decreased appetite, insomnia, headache, tremors, tachycardia	Dizziness, decreased seizure threshold, blurred vision and other vision changes
Lisdexamphetamine [27]	Vyvanse	Decreased appetite (39%), insomnia, (22%), upper abdominal pain (12%), irritability (10%)	Dizziness (5%), affect lability (3%), anorexia (2%)
Dextroamphetamine [29]	Xelstrym patch	Decreased appetite (12%), insomnia (8%), headache (6%), abdominal pain/vomiting (4%)	Affect lability (3%), irritability (2%)
Dextroamphetamine sulfate [32]	Attentin	Decreased appetite (14%), depressed mood (2%), abdominal pain (1%)	Decreased weight (1%)

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