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 33^rd 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
In the randomized, double-blind, placebo-controlled Phase 3 study, 320 adults 18 to 55 years of age with ADHD were randomized to receive either AR19 20 mg (n=107), AR19 40 mg (n=107) or placebo (n=106) daily for five weeks.

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
Researchers are presenting results from two surveys of young adults including college students and those in fraternities or sororities about their nonmedical use (NMU) of prescription stimulant medications, preferred routes of administration and motivations. Surveys were conducted by Inflexxion and fielded through YouGov, an online data analytics and survey platform.

Survey of College Students who Nonmedically Use Prescription Stimulants

• Only 43% of 583 college students 18 to 26 years of age surveyed reported having received an ADHD diagnosis.
• Among respondents with an ADHD diagnosis and a prescription stimulant, 65% were asked to divert their medication, and two-thirds of those actually did divert their medication.
• Of respondents diagnosed with ADHD who have taken a prescribed medication for ADHD, 64% reported modifying the medication, and 47% reported having taken the medication via at least one non-oral route, most frequently by snorting (45%).
• Among college students with ADHD who reported taking more medication than prescribed, reasons included "to enhance performance at work/school" (61%), "for energy" (51%), "to treat ADHD/regular dose wasn't working" (44%), "to improve mood/elevate spirit" (35%), and "to get high" (22%). The most commonly cited motivation for modifying a prescribed ADHD medication for snorting included "to achieve a faster effect on ADHD symptoms" (52%) and "to achieve a faster high" (31%).

Prescription Stimulant NMU Surveys of College Students, Fraternity/Sorority Members and Young Adults

• Researchers surveyed 3,011 young adults 18 to 26 years of age including college students in fraternities or sororities (N=157), college students not involved in Greek life (N=1,199) and a control group of young adults not enrolled in college (N=1,655).
• Lifetime prescription stimulant NMU among Greek students (15.9%) was more than twice as high as non-Greek students (6.0%, p<0.0001) and three times higher than the control group (5.3%, p<0.001). Nearly half (48%) of Greek students reported prescription stimulant NMU by non-oral routes, primarily by snorting (44%). Non-Greek students were significantly less likely to report non-oral NMU (15.3%, p<0.001) and snorting (13.9%, p=0.002).
• Depression and anxiety diagnoses were common among all groups; however, Greek students who reported prescription stimulant NMU were more likely to be diagnosed with ADHD, bipolar disorder, substance/alcohol use disorders, learning disabilities, oppositional defiant disorder and 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, 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
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 misuse and abuse of prescription stimulant ADHD treatments. Today, Arbor Pharmaceuticals markets three ADHD treatments and is developing several potential new treatment options in addition to 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 info@arborpharma.com.

Contact:
Tom Rovine
Tom.Rovine@mboothhealth.com
212‑886‑2263

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SOURCE Arbor Pharmaceuticals, LLC