Arbor Pharmaceuticals Announces FDA Filing Acceptance of New Drug Application (NDA) for AR19, an Investigational ADHD Prescription Stimulant Treatment Specifically Designed to Resist Physical Manipulation for Nonmedical Misuse or Abuse

ATLANTA, May 13, 2020 /PRNewswire/ -- Arbor Pharmaceuticals, LLC, a U.S.-based specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for AR19, an investigational immediate-release, amphetamine capsule for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children 3-17 years of age and in adults 18 and older. AR19 has been specifically designed to resist potential manipulation. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 15, 2020.

"While stimulants are essential first-line therapies for ADHD, they are associated with potentially dangerous risks and side effects when used nonmedically, especially via non-oral routes of administration," said Evan Scullin M.D., Medical Director, Arbor Pharmaceuticals. "Arbor has designed AR19 to resist manipulation to help address this public health concern of non-oral use, and we look forward to working closely with the FDA as it reviews our application."

"Given the growth of nonmedical use of stimulant medications among the U.S. population, the development of a manipulation-resistant formulation of amphetamine is extremely important," said Anthony Rostain, M.D., Chair of Cooper University Healthcare Department of Psychiatry and Behavioral Health and Professor Emeritus, Perelman School of Medicine, University of Pennsylvania. "It's a vital step in making these helpful medications safer to use in clinical practice."

Nonmedical use of prescription stimulants often begins in adolescence, and an estimated 1.7 million people aged 12 and older have used stimulants nonmedically within the past month.¹ In a national survey of more than 19,000 college students, 16 percent reported nonmedically using stimulant medications, making them the most commonly misused prescription drugs on campuses, and the majority reported receiving the medications from a friend. In addition, a substantial proportion of nonmedical users report non-oral administration, or snorting, injecting or smoking prescription stimulants.² In a recent survey of college students, snorting was reported by 21 percent of non-medical users, making intranasal administration the most prevalent non-oral route of stimulant nonmedical use.³ 

This problem is not limited to college students; a recent survey of children age 10-17 demonstrated that 30 percent of respondents with access to prescription stimulants had used them nonmedically and 45 percent of those nonmedical users had used non-orally.⁴ It is important to note that non-oral administration is associated with more severe clinical adverse effects, including death.^5,6 

The AR19 NDA is supported by a comprehensive clinical program including studies that support the compound's safety and efficacy for the treatment of children and adults and its manipulation-resistant properties.

ABOUT ARBOR PHARMACEUTICALS' HERITAGE IN ADHD TREATMENT
For nearly a decade, Arbor Pharmaceuticals has been committed to improving treatment of ADHD by developing innovative medicines and supporting research that drives greater understanding of the disease and the risks of nonmedical use of prescription stimulant ADHD treatments. Today, Arbor Pharmaceuticals markets three ADHD treatments and is developing several potential new treatment options including AR19.

ABOUT ARBOR PHARMACEUTICALS, LLC
Arbor Pharmaceuticals, headquartered in Atlanta, Georgia, is a specialty pharmaceutical company currently marketing FDA-approved prescription products in the neuroscience, cardiovascular, and hospital markets. In addition to an extensive pipeline, the company continues to actively pursue growth through acquisition or licensing of late-stage development products. For more information regarding Arbor Pharmaceuticals or any of its products, visit www.arborpharma.com or send email inquiries to [email protected].

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¹ Substance Abuse and Mental Health Services Administration. Key Substance Use and Mental Health Indicators in the United States. Results from the 2018 National Survey on Drug Use and Health: Detailed Tables (HHS Publication No. PEP19-5068, NSDUH Series H-54). Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. (2018). Available at https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHDetailedTabs2018R2/NSDUHDetTabsSect1pe2018.htm
² Phillips, Erica L. & McDaniel, Anne E. (2018). College Prescription Drug Study Key Findings Report. Center for the Study of Student Life, The Ohio State University: Columbus, Ohio.
³ Green J, Inflexxion. YouGov College Population Study, AR19.MA006, 2018.
⁴ Cottler LB. The Study of Non-Oral Administration of Prescription Stimulants (SNAPS), AR19.MA010 (US), 2019.
⁵ Cassidy TA et al. Nonmedical use and diversion of ADHD stimulants among U.S. adults ages 18-49: a national Internet survey. J Attention Disorders, 2015;19:630-640.
⁶ Faraone SV et al. Prevalence and consequences of the nonmedical use of amphetamine among persons calling poison control centers. J Attention Disorders, 2019;23:1219-1228. AR19.MA001 (US).

PP-AR19-US-0003

SOURCE Arbor Pharmaceuticals, LLC

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