AR19, an investigational stimulant for attention-deficit/hyperactivity disorder (ADHD), improved symptoms in adults with ADHD in a Phase 3 randomized, double-blind, placebo-controlled trial, according to a poster presented at Psych Congress 2020.
The study randomized 320 adults, aged 18 to 55 years, to receive either 20 mg of AR19, 40 mg of AR19, or placebo daily for 5 weeks. Both doses of AR19 met the primary efficacy endpoint—symptom improvement as measured by the Adult ADHD Investigator Symptom Rating Scale. On the scale, which has a maximum score of 54, the least square mean treatment difference vs placebo -7.2 for the 20 mg group and -7.3 for the 40 mg group.
AR19 is an immediate-release amphetamine sulfate capsule designed to resist physical manipulation for non-oral use such as snorting, smoking, and injecting. It is currently under review by the US Food and Drug Administration, with a Prescription Drug User Fee Act target action date of November 15, 2020.
"Based on these findings, along with comprehensive studies demonstrating AR19's manipulation resistance properties, we hope to bring to the ADHD community a new first-line stimulant option that would support a broader harm reduction strategy that may reduce the risks and dangerous outcomes of non-oral misuse and abuse." said Evan Scullin, MD, Arbor Pharmaceuticals’ vice president of medical affairs.
The trial demonstrated a safety profile for AR19 similar to that of Arbor’s Evekeo (amphetamine sulfate tablets), an approved ADHD treatment that contains the same active ingredient. The most commonly reported treatment-emergent adverse events among people taking AR19 were insomnia, dry mouth, decreased appetite, palpitations, and tachycardia; 7 participants in the AR19 groups left the study due to adverse events.
Surveys Illustrate Prevalence of Stimulant Abuse
Also at Psych Congress, researchers presented findings from 2 surveys of young adults about their nonmedical use (NMU) of prescription stimulants, preferred routes of administration, and motivations.
Within a group of 583 college students aged 18 to 26 years, 43% reported having an ADHD diagnosis. Among those students who also had been prescribed a stimulant, 65% reported they had been asked to divert their medication, and two-thirds of those said they did so.
Nearly two-thirds of respondents with a diagnosis and prescription for ADHD reported modifying the medication, and 47% reported having taken the medication via at least one non-oral route, with snorting the most common method (45%).
Another study surveyed 3011 young adults aged 18 to 26 years, including 157 college students in fraternities or sororities, 1199 college students not involved in Greek life, and a control group of 1655 young adults not in college.
Lifetime prescription stimulant NMU among Greek students was 15.9%, more than twice as high as among non-Greek students (6%) and three times higher than in the control group (5.3%). Nearly half of Greek students reported prescription stimulant NMU by non-oral routes, with 44% reporting snorting. Non-Greek students were significantly less likely to report non-oral NMU (15.3%) or snorting (13.9%).
The study also found Greek students who reported prescription stimulant NMU were more likely to have diagnoses of ADHD, bipolar disorder, substance/alcohol use disorders, learning disabilities, oppositional defiant disorder, or conduct disorder.
"These results reveal an alarming prevalence of intranasal prescription stimulant NMU among college students and especially those within the Greek system," said study author Stephen V. Faraone, PhD, Distinguished Professor of Psychiatry and Neuroscience & Physiology at SUNY Upstate Medical University, Syracuse, New York. "Knowing why college students misuse and abuse prescription stimulants non-orally and the specific risks associated with Greek life can help college health officials and other stakeholders take informed steps to educate and reduce the burden of this dangerous practice."
Arbor presents data from pivotal study of AT19, an investigational ADHD prescription stimulant treatment specifically designed to resist physical manipulation for nonmedical misuse or abuse [press release]. Atlanta, GA: Arbor Pharmaceuticals, LLC; September 10, 2020.
Faraone S, 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. Poster presented at Psych Congress 2020; September 10-13, 2020; Virtual.
Green J, Antshel K, Faraone S, et al. Attention Deficit Hyperactivity Disorder (ADHD), college students, and nonmedical use of prescription stimulants via high risk routes of administration. Poster presented at Psych Congress 2020; September 10-13, 2020; Virtual.
Green J, Antshel K, Faraone S, et al. College students involved in Greek life are at higher risk for nonmedical use of prescription stimulants, particularly via non-oral routes. Poster presented at Psych Congress 2020; September 10-13, 2020; Virtual.