Arbor Presents Data from Pivotal Study of AR19, an Investigational ADHD Prescription Stimulant Treatment Specifically Designed to Resist Physical Manipulation for Nonmedical Misuse or Abuse
ATLANTA, Sept. 10, 2020 /PRNewswire/ -- Arbor Pharmaceuticals, LLC, a U.S.-based specialty pharmaceutical company, announced today the presentation of positive safety and efficacy results from the pivotal Phase 3 study in adults of AR19, its investigational immediate-release, amphetamine sulfate capsule for the treatment of attention-deficit/hyperactivity disorder (ADHD). AR19 is currently under review by the U.S. Food and Drug Administration (FDA) as a potential ADHD treatment specifically designed to resist manipulation for non-oral use (i.e., snorting, smoking and injecting). Researchers are presenting the study findings at the 33rd annual Psych Congress, along with new data on the prevalence of and motivations for non-oral misuse and abuse of prescription stimulants among college students.
The Phase 3 data being presented support Arbor's New Drug Application (NDA) for AR19, which also includes data demonstrating that AR19 resists manipulation for nonmedical misuse and abuse by non-oral routes of administration; these data will be presented at the 2020 American Academy of Child and Adolescent Psychiatry (AACAP) Annual Meeting in October. The Prescription Drug User Fee Act (PDUFA) target action date for AR19 is November 15, 2020.
"We are pleased to share AR19 safety and efficacy data with the medical community that affirm its value as a potential treatment for ADHD," said Evan Scullin, M.D., Vice President of Medical Affairs, Arbor Pharmaceuticals. "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."
Study AR19.004 demonstrates safety and efficacy of AR19 for ADHD in adults
Both doses of AR19 met the primary efficacy endpoint of symptom improvement according to the Adult ADHD Investigator Symptom Rating Scale (AISRS), a validated measure of ADHD symptom severity in which higher scores indicate more severe symptoms with a maximum score of 54. In pairwise comparisons using an analysis of least square means to compare treatment differences in AISRS at visit 7 for AR19 versus placebo, the differences were -7.2 for the AR19 20 mg group and -7.3 for the AR19 40 mg group (each P<0.001), representing significant symptom improvement with both doses of AR19.
The most commonly reported treatment-emergent adverse events (TEAEs) reported by >5% of patients in the AR19 20 mg or AR19 40 mg group were insomnia (8.4%, 9.3%), dry mouth (5.6%, 11.2%), decreased appetite (10.3%, 13.1%), palpitations (1.9%, 6.5%) and tachycardia (abnormally rapid heart rate) (5.6%, 3.7%). Seven participants in the AR19 groups experienced TEAEs that led to study drug discontinuation. This safety profile is consistent with that of Evekeo® (amphetamine sulfate tablets), Arbor's approved ADHD treatment that contains the same active ingredient as AR19.
Surveys of college students illuminate prevalence of non-oral misuse and abuse
Survey of College Students who Nonmedically Use Prescription Stimulants
Prescription Stimulant NMU Surveys of College Students, Fraternity/Sorority Members and Young Adults
"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, Ph.D., Distinguished Professor of Psychiatry and Neuroscience & Physiology at SUNY Upstate Medical University. "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."
ABOUT ARBOR PHARMACEUTICALS' HERITAGE IN ADHD TREATMENT
ABOUT ARBOR PHARMACEUTICALS, LLC
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SOURCE Arbor Pharmaceuticals, LLC