What question did this study set out to answer?

To assess the efficacy, safety, and tolerability of forced-dose SHP465 mixed amphetamine salts (MAS) compared with placebo in adults with attention-deficit/hyperactivity disorder.

July 15, 2017CNS DrugsOpen Access

Efficacy and Safety of SHP465 Mixed Amphetamine Salts in the Treatment of Attention-Deficit/Hyperactivity Disorder in Adults: Results of a Randomized, Double-Blind, Placebo-Controlled, Forced-Dose Clinical Study

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Authors

RWRichard H. WeislerUniversity of North Carolina at Chapel Hill MGMichael GreenbaumRowan University VAValerie ArnoldLaunchpad Central (United States)

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Implication

Randomized double-blind trial demonstrates SHP465 mixed amphetamine salts significantly reduce symptoms in adults with ADHD, indicating robust efficacy with a standard stimulant safety profile.

Key Points

To assess the efficacy, safety, and tolerability of forced-dose SHP465 mixed amphetamine salts (MAS) compared with placebo in adults with attention-deficit/hyperactivity disorder.
Randomized, double-blind, placebo-controlled, forced-dose trial (NCT02604407) conducted over 4 weeks in 275 adults aged 18–55 years randomized 1:1:1 to placebo (n = 91), 12.5 mg/day SHP465 MAS (n = 92), or 37.5 mg/day SHP465 MAS (n = 92).
The primary endpoint was change from baseline to week 4 on the ADHD Rating Scale with Adult Prompts (ADHD-RS-AP) total score, evaluated alongside Clinical Global Impressions-Improvement (CGI-I) scores using linear mixed-effects models for repeated measures.
Both SHP465 MAS doses produced significant reductions in ADHD-RS-AP total score versus placebo at week 4 (12.5 mg/day least-squares mean difference: −8.1 [95% CI, −11.7 to −4.4], effect size = 0.67, p < 0.001; 37.5 mg/day: −13.4 [95% CI, −17.1 to −9.7], effect size = 1.11, p < 0.001).
Key secondary CGI-I scores significantly favored SHP465 MAS over placebo at week 4 (12.5 mg/day difference: −0.8 [95% CI, −1.1 to −0.4], effect size = 0.68, p < 0.001; 37.5 mg/day: −1.2 [95% CI, −1.6 to −0.9], effect size = 1.11, p < 0.001).
Adverse events reported in >5% of SHP465 MAS participants included decreased appetite, dry mouth, insomnia, headache, anxiety, and irritability; mild mean increases in pulse and blood pressure were observed without reports of suicidal ideation.

Cite This Study

Weisler et al. (2017) studied this question.

synapsesocial.com/papers/6a834161dfd29b4838ca9b45 https://doi.org/10.1007/s40263-017-0455-7

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Implication

Randomized double-blind trial demonstrates SHP465 mixed amphetamine salts significantly reduce symptoms in adults with ADHD, indicating robust efficacy with a standard stimulant safety profile.

Efficacy and Safety of SHP465 Mixed Amphetamine Salts in the Treatment of Attention-Deficit/Hyperactivity Disorder in Adults: Results of a Randomized, Double-Blind, Placebo-Controlled, Forced-Dose Clinical Study

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Cite This Study

Efficacy and Safety of SHP465 Mixed Amphetamine Salts in the Treatment of Attention-Deficit/Hyperactivity Disorder in Adults: Results of a Randomized, Double-Blind, Placebo-Controlled, Forced-Dose Clinical Study

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