New Research: Two Types of Amphetamines Shown to Effectively Treat ADHD in Adults

UPDATE: On October 8, 2020, an FDA advisory committee on drug safety and risk management unanimously voted not to recommend approval for the ADHD medication AR19 — saying the risks associated with the fast-release amphetamine sulfate outweigh its benefits. The Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee concluded that AR19, which was designed to resist manipulation for non-oral use, could be more dangerous than conventional stimulants used to treat ADHD. The drug appeared safe when administered orally, but the committee found that high levels of talc and polyethylene oxide in the drug’s composition could be toxic if taken through snorting or injection. The committees also voted that drug maker Arbor Pharmaceuticals did not adequately address the safety of AR19 and did not adequately demonstrate how AR19 would deter intravenous use or intranasal use.

September 15, 2020

New research¹ suggests that two novel types of amphetamines may effectively treat attention deficit hyperactivity disorder (ADHD or ADD) in adults: SHP465 mixed amphetamine salts (MAS) and AR19 fast-release amphetamine sulfate. The findings were announced at the Psych Congress Virtual Experience from September 11 to 13.

The investigational stimulant AR19 is a pellets-in-capsule, fast-release amphetamine sulfate with physical and chemical barriers designed to prevent abuse by snorting, smoking, and intravenous injection. A randomized-control trial² was conducted on adults with ADHD, ages 18-55 years, to assess the safety and efficacy of AR19. 320 patients were randomly assigned placebo, 107 were assigned a 20 mg dose of AR19, and 107 were assigned a 40 mg dose.

According to the Adult ADHD Investigator Symptom Rating Scale, both doses of AR19 were associated with significant symptom improvement. The most common side effects were insomnia, dry mouth, headache, decreased appetite, palpitations, and tachycardia.

“What differentiates AR19 are its barriers to manipulation for non-oral use, which may provide an important benefit for reducing the dangerous risks associated with snorting, smoking, and injecting prescription stimulants,”³ said Stephen Faraone, Ph.D., in the publication MedPage Today, explaining how AR19 differs from other amphetamine sulfates, such as Adderall XR.

AR19 is currently under review by the U.S. Food and Drug Administration (FDA) as a potential ADHD treatment specifically designed to resist manipulation. The research presented last week represented the Phase 3 data to support Arbor Pharmaceuticals’ New Drug Application (NDA).

SHP465 is an extended-release, once-daily MAS approved by the FDA for the treatment of ADHD in patients aged 13 years and older. It contains equal amounts of dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate, and amphetamine aspartate monohydrate.

In the new research, SHP465 was found to reduce symptoms of ADHD in adults independent of ADHD treatment history. Two placebo-controlled studies⁴ of SHP465 MAS were analyzed. The first was a 7-week, dose-optimization study and the second was a 6-week, fixed-dose study. Both studies suggest that SHP465 MAS effectively reduces ADHD symptoms — namely, inattention, distractibility, and sustained effort — in adults with and without prior stimulant exposure. The most common side effects, reported by 5% or more of subjects treated with SHP465 MAS, included insomnia, decreased appetite, dry mouth, headache, and anorexia.

The study faced several limitations — namely that more than 80% of participants were white and most had combined-type ADHD — suggesting further researcher is need to assess the efficacy of the drug in the wider population. This study was funded by Shire Development, LLC, a member of the Takeda group of companies.

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