Investigational Stimulant Found Effective, Safe for Treatment of ADHD Symptoms in Adults

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Investigators conducted a randomized clinical trial to assess the safety and efficacy of the investigational stimulant AR19 for the treatment of symptoms of attention-deficit/hyperactivity disorder in adults.

The following article is a part of conference coverage from Psych Congress 2020 Virtual Experience, held virtually from September 10 to 13, 2020. The team at Psychiatry Advisor will be reporting on the latest news and research conducted by leading experts in psychiatry. Check back for more from the Psych Congress 2020.


The investigational stimulant AR19 was found to safely improve symptoms of attention-deficit/hyperactivity disorder (ADHD) in adult patients, according to study data presented at Psych Congress 2020 Virtual Experience, held online from September 11 to 13, 2020. AR19 is a pellets-in-capsule, fast-release amphetamine sulfate with physical and chemical barriers designed to prevent abuse by snorting, smoking, and intravenous injection.

Investigators conducted a randomized clinical trial to assess the safety and efficacy of AR19 for the treatment of ADHD. Adults aged 18 to 55 years with a clinical diagnosis of ADHD were recruited from clinics around the United States. Patients were randomly assigned AR19 20 mg/d, AR19 40 mg/d, or placebo. Study medications were administered once in the morning and again 4 to 6 hours later for a duration of 5 weeks. Follow-up examinations were performed at weekly clinic visits. The primary outcome was change in Adult ADHD Investigator Symptom Rating Scale (AISRS) score between baseline and week 5. Adverse events were monitored throughout the trial duration.

A total of 320 patients were randomly assigned to placebo (n=106), AR19 20 mg (n=107), and AR19 40 mg (n=107). Baseline demographic and clinical characteristics were comparable across treatment arms. The majority of participants were White (80.3%); 54.4% were men, and mean age was 34.4 ± 10.2 years. The least squares mean treatment difference compared with placebo was -7.0 (97.5 CI, -11.1 to -3.0) in the AR19 20-mg group and -7.0 (-11.0 to -2.9) in the AR19 40-mg group (both P <.001). In patients taking AR19, the most common adverse events were insomnia (8.4% of 20-mg group; 9.3% of 40-mg group), dry mouth (5.6%; 11.2%), headache (13.1%; 11.2%), decreased appetite (10.3%; 13.1%), palpitations (1.9%; 6.5%), and tachycardia (5.6%; 3.7%). Adverse events were most frequently reported during the titration phase. A total of 10 participants reported 23 adverse events that resulted in drug discontinuation: 3 in the placebo group, 2 in the AR-19 20 mg group, and 5 in the AR-19 40 mg group. The most common events leading to discontinuation of treatment were palpitations, insomnia, decreased appetite, feeling “abnormal,” and hyperhidrosis.

Overall, these data support the safety and efficacy of AR19 20 mg and 40 mg for the treatment of symptoms of ADHD in adults. However, larger-scale clinical trials are necessary to confirm these results.

Disclosure: This study was sponsored by Arbor Pharmaceuticals, LLC. Please see the original reference for a full list of authors’ disclosures.

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Childress A, Faraone SV, Rostain A, Caras S. A randomized, placebo-controlled trial to evaluate the efficacy and safety of AR19 (amphetamine sulfate) in adults with attention-deficit/hyperactivity disorder. Presented at: Psych Congress 2020 Virtual Experience; September 11-15, 2020. Abstract 105.