‘Abuse Deterrent’ ADHD Tx May Face Uphill Approval Path

An abuse-deterrent stimulant product for attention deficit-hyperactivity disorder (ADHD) got a skeptical review from FDA technical staff ahead of an advisory committee meeting later this week.

AR19 is an oral amphetamine sulfate immediate-release capsule formulated to reduce non-oral abuse. The drug, developed by Arbor Pharmaceuticals, will go before the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee on Thursday.

The main question looming over AR19 is whether it will indeed deter intranasal and IV abuse through its novel formulation. In briefing documents prepared for panel members, FDA staff suggested they weren’t persuaded by the company’s studies.

Non-medical use of prescription stimulants has remained relatively stable since 2010 and, in 2018, 2% of the U.S. population was misusing stimulants, according to the briefing documents. Young adults are more likely than adults of other ages to misuse stimulants, and the vast majority of misuse occurs

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