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NEW YORK -- Extended-release SHP465 mixed amphetamine salts (MAS) improved attention-deficit hyperactivity disorder (ADHD) symptoms and executive function in adults regardless of baseline sleep quality, researchers reported here.

Although the effects of the treatment tended to be greater in patients with impaired sleep, SHP465 MAS (MYDAYIS) treatment was still favored over placebo for improvement in ADHD-RS-IV score over the 7-week analysis regardless of sleep disturbance at baseline (all nominal P<0.001), according to Craig B. Surman, MD, of Massachusetts General Hospital in Boston, and colleagues. Specifically:

• Days dysfunctional due to sleepiness, impaired versus not impaired: Least squares mean (LSM) difference -9.5 (95% CI -13.7 to -5.3) versus –7.8 (95% CI -10.9 to -4.7)
• Sleep disturbance: LSM -10.6 (95% CI -15.0 to -6.3) versus -6.8 (95% CI -9.8 to -3.7)
• Sleep latency: LSM -7.7 (95% CI -11.7 to -3.7) versus -8.8 (95% CI -12.1 to -5.6)

The post-hoc analysis of the phase III randomized, placebo-controlled trial included participants with a confirmed diagnosis of ADHD, according to the DSM-IV-TR criteria, he said in a presentation at the American Psychiatric Association annual meeting.

Similarly, Brown Attention Deficit Disorder Scale (BADDS) total score also showed improvement among those with or without sleep impairment with SHP465 MAS treatment:

• Days dysfunctional due to sleepiness, impaired versus not impaired: LSM -18.7 (95% CI -28.5 to -9.0) [impaired] versus -15.7 (95% CI -23.0 to -8.4)
• Sleep disturbance: LSM -18.1 (95% CI –28.6 to –7.7) versus –15.2 (95% CI –22.1 to –8.2)
• Sleep latency: LSM -14.3 (95% CI -23.7 to -4.8) versus -17.7 (95% CI -25.1 to -10.2)

The treatment contains an equal combination of dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate, and amphetamine aspartate monohydrate in immediate and delayed-release beads.

For the study by Surman's group, 272 patients were randomized at 39 U.S. sites. The mean age of patients in the study arm was 36.1, 50.7% were men, and 86% were Caucasian. The majority had combined ADHD subtype (inattentive; hyperactive/impulsive).

Half received SHP465 MAS treatment beginning at a daily dose of 12.5 mg, and increasing each week to 25 mg, 50 mg, and then to 75 mg, until optimal dose was reached marked by at least a 30% decrease in baseline ADHD-RS-IV score.

Individuals were excluded from the analysis due to preexisting comorbid psychiatric diagnosis, cardiac conditions, a history of substance abuse, or if currently taking medications contraindicated with or that could confound the study.

Poor sleep quality is a common problem among adults with ADHD, explained Manisha Madhoo, MD, vice president of global medical affairs of neuroscience at Shire Development of Lexington, Massachusetts, the agent's developer.

"It's really helpful to the patients, and more important to the physicians, to have information that ... shows whether baseline quality impacts response to treatment with MYDAYIS on ADHD symptoms and executing function versus placebo," Madhoo told 番茄社区app.

The once-daily, sustained release triple-bead oral treatment for adults with ADHD was approved by the FDA in 2017 for use in patients ≥13 years. It delivers 16 hours of sustained therapy, filling an "unmet need" in ADHD treatment, Madhoo stated.

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