A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of AR19, a Manipulation-Resistant Formulation of Amphetamine Sulfate, in Adults With Attention-Deficit/Hyperactivity Disorder

References (21)

1. Willcutt EG. The prevalence of DSM-IV attention-deficit/hyperactivity disorder: a meta-analytic review. Neurotherapeutics. 2012;9(3):490–499. PubMed CrossRef
2. Simon V, Czobor P, Bálint S, et al. Prevalence and correlates of adult attention-deficit hyperactivity disorder: meta-analysis. Br J Psychiatry. 2009;194(3):204–211. PubMed CrossRef
3. Wolraich ML, Hagan JF Jr, Allan C, et al; Subcommittee on Children and Adolescents With Attention-Deficit/Hyperactive Disorder. Clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics. 2019;144(4):e20192528. PubMed CrossRef
4. Faraone SV, Asherson P, Banaschewski T, et al. Attention-deficit/hyperactivity disorder. Nat Rev Dis Primers. 2015;1(1):15020. PubMed CrossRef
5. Safer DJ. Recent trends in stimulant usage. J Atten Disord. 2016;20(6):471–477. PubMed CrossRef
6. National Prescription Audit, Stimulant Mediations. Danbury, CT & Research Triangle Park, NC: IQVIA; 2019.
7. Faraone SV, Rostain AL, Montano CB, et al. Systematic review: nonmedical use of prescription stimulants: risk factors, outcomes, and risk reduction strategies. J Am Acad Child Adolesc Psychiatry. 2020;59(1):100–112. PubMed CrossRef
8. Cassidy TA, Varughese S, Russo L, et al. Nonmedical use and diversion of ADHD stimulants among US adults ages 18-49: a national internet survey. J Atten Disord. 2015;19(7):630–640. PubMed CrossRef
9. Faraone SV, Hess J, Wilens T. Prevalence and consequences of the nonmedical use of amphetamine among persons calling poison control centers. J Atten Disord. 2019;23(11):1219–1228. PubMed CrossRef
10. FDA response to citizen petition. Docket No. FDA-2006-P-0453. Food and Drug Administration. September 18, 2014. https://www.fdanews.com/ext/resources/files/09-14/09-30-14-FDAresponse.pdf?1520755155
11. Food and Drug Administration. The Food and Drug Administration Solicits Input on Potential Role for Abuse-Deterrent Formulations of Central Nervous System Stimulants. Docket No. FDA–2019–N–3403. Govinfo. September 16, 2019. https://www.govinfo.gov/content/pkg/FR-2019-09-20/pdf/2019-20372.pdf.
12. Evekeo [package insert]. Atlanta, GA: Arbor Pharmaceuticals, LLC; 2019.
13. Rostain AL, Caras S, Mills C, et al. Abuse potential of manipulated amphetamine sulfate (AR19) when administered intranasally to nondependent recreational stimulant users. Paper presented virtually at 67th Annual Meeting of the American Association of Child and Adolescent Psychiatry; October 23, 2020.
14. Caras S, Sharpe T. Pharmacokinetics of AR19, an immediate-release amphetamine sulfate formulation designed to deter manipulation for administration via nonoral routes: bioequivalence to reference racemic amphetamine sulfate, dose proportionality, and food effect. J Child Adolesc Psychopharmacol. 2020;30(2):69–80. PubMed CrossRef
15. Childress AC, Brams M, Cutler AJ, et al. The efficacy and safety of Evekeo, racemic amphetamine sulfate, for treatment of attention-deficit/hyperactivity disorder symptoms: a multicenter, dose-optimized, double-blind, randomized, placebo-controlled crossover laboratory classroom study. J Child Adolesc Psychopharmacol. 2015;25(5):402–414. PubMed CrossRef
16. Epstein JN, Johnson D, Conners CK. Conners’ Adult ADHD Diagnostic Interview for DSM-IV. North Tonawanda, NY: Multi-Health Systems, Inc; 2000.
17. Spencer TJ, Adler LA, Meihua Qiao, et al. Validation of the adult ADHD Investigator Symptom Rating Scale (AISRS). J Atten Disord. 2010;14(1):57–68. PubMed CrossRef
18. Guy W. Clinical Global Impressions (CGI) Scale, Modified. In: Rush JA, Task Force for the Handbook of Psychiatric Measures, eds. Handbook of Psychiatric Measures. 1st ed. Washington, DC: American Psychiatric Association; 2000.
19. Roth R, Isquith P, Gioia G. Behavior Rating Inventory of Executive Function—Adult Version [BRIEF-A]. Lutz, FL: Psychological Assessment Resources; 2005.
20. Posner K, Brown GK, Stanley B, et al. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011;168(12):1266–1277. PubMed CrossRef
21. Faraone SV. The pharmacology of amphetamine and methylphenidate: relevance to the neurobiology of attention-deficit/hyperactivity disorder and other psychiatric comorbidities. Neurosci Biobehav Rev. 2018;87:255–270. PubMed CrossRef