The Arbor Pharmaceutical drug is aimed at treating ADHD without being manipulated for non-oral use.
The US Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee is not recommending approval for AR19, an investigational immediate-release, amphetamine sulfate capsule for the treatment of attention-deficit/hyperactivity disorder (ADHD).
With a 19-2 vote, the advisory committee deemed the Arbor Pharmaceutical treatment had safety risks that ultimately outweighed the benefit of the medication. The advisory committee also voted 15-8 during the Oct. 8 hearing that the drug would ultimately deter intravenous use. In addition, they voted 19-4 that the company did not demonstrate it would deter intranasal use with AR19.
AR19 is specifically designed to resist manipulation for non-oral use, such as snorting, smoking, and injecting. Recently, Arbor presented data from a randomized, double-blind, placebo-controlled phase 3 study involved 320 adult ADHD patients. Each patient was randomized to receive either AR19 20 mg (n = 107), AR19 40 mg (n = 107), or placebo (n = 106) daily for 5 weeks.
Both doses of the study drug met the primary efficacy endpoint involving symptom improvement according to the Adult ADHD Investigator Symptom Rating Scale (AISRS). 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.
Treatment-emergent adverse events that occurred in more than 5% of patients included 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%). The safety profile is consistent with Arbor’s Evekeo, an approved ADHD treatment with the same active ingredient as AR19.
The company has a Prescription Drug User Fee Act (PDUFA) target action date of November 15, 2020.