Each capsule contains three types of drug-releasing beads, an immediate-release bead and two different types of delayed-release beads. This results in a 3:1 mixture of dextro- to levoamphetamine base equivalent. It contains equal amounts (by weight) of four salts: dextroamphetamine sulfate and amphetamine sulfate, dextroamphetamine saccharate and amphetamine aspartate monohydrate. SHP465 MAS was designed with the goal of providing a medication with the potential to reduce the ADHD symptoms throughout the day and into the evening in individuals who require such coverage. SHP465 mixed amphetamine salts (SHP465 MAS) is a novel, once-daily, extended-release, single-entity MAS product for oral administration approved in USA for the treatment of ADHD in patients aged 13 years and older. In a clinical program practice survey of adults being treated for ADHD, approximately 40% of patients were receiving a combination of short- and long-acting psychostimulants. Although reviews suggest that currently available long-acting psychostimulants have estimated durations of effect ranging from 8 to 14 h, some physicians may augment their patients’ long-acting psychostimulant with another ADHD medication later in the day because the long-acting psychostimulant alone does not provide all-day coverage. When pharmacotherapy for adults diagnosed with ADHD is pursued, the initial treatment choice is generally a psychostimulant, which is in accordance with US practice recommendations for children and adolescents with ADHD. No participant in any treatment group had a positive response for on-study Columbia-Suicide Severity Rating Scale assessments.Īttention-deficit/hyperactivity disorder (ADHD) presents clinically in children and adolescents, and it may persist in a sizeable portion of adults. Severe treatment-emergent adverse events and treatment-emergent adverse events leading to discontinuation, respectively, were reported by 8 and 12 participants (placebo, n = 2 and 0 12.5 mg/day SHP465 MAS, n = 1 and 7 37.5 mg/day SHP465 MAS, n = 5 and 5). Least-squares mean (95% confidence interval) treatment differences at week 4 significantly favored SHP465 MAS over placebo for the ADHD-RS-AP total score change from baseline [12.5 mg/day: −8.1 (−11.7, −4.4), effect size = 0.67 37.5 mg/day: −13.4 (−17.1, −9.7), effect size = 1.11 both p 5%) with SHP465 MAS were decreased appetite, dry mouth, insomnia, headache, anxiety, initial insomnia, irritability, and bruxism.
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