Background: AR19 is a pellets-in-capsule, immediate-release amphetamine sulfate investigational formulation with physical and chemical barriers designed to resist manipulation to deter snorting, smoking and intravenous injection. This was a randomized, double-blind, placebo-controlled, fixed-dose, multicenter trial that investigated the safety and efficacy of AR19 in the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults from 18 through 55 years of age.
Methods: Study participants were randomized and titrated to 20 mg or 40 mg AR19 daily or placebo. Study medication was dosed once in the morning and again 4 to 6 hours later for a period of 5 weeks.
Results: A total of 320 participants were randomized and received at least 1 dose of study medication. Demographics and baseline characteristics were similar across treatment groups. The primary efficacy measure was the total score on the Adult ADHD Investigator Symptom Rating Scale (AISRS). The least square mean treatment difference vs placebo (97.5% CI) was -7.0 (-11.1, -3.0) for the AR19 20 mg group and -7.0 (-11.0, -2.9) for the AR19 40 mg group (each P < 0.001). The most common TEAEs considered related to AR19 were insomnia, dry mouth, decreased appetite, palpitations, tachycardia, and hyperhidrosis, and are consistent with the known safety profile of amphetamine sulfate.
Conclusion: AR19 was generally well tolerated and all efficacy endpoints were met, supporting the efficacy and safety of AR19 dosage regimens of 20 mg and 40 mg in adults with ADHD.