Positive results have been reported from a four-week, randomized, double-blind, multicenter, parallel-group, placebo-controlled, forced-dose titration, efficacy, and safety study of SHP465 (triple-bead mixed amphetamine salts, Shire) in 275 adults (18 to 55 years of age) with attention-deficit/hyperactivity disorder (ADHD). SHP465 is an investigational oral stimulant medication being evaluated in the United States as a potential treatment for ADHD.
The study’s primary efficacy analysis showed that SHP465 12.5 mg and 37.5 mg, both administered as a daily morning dose, were superior to placebo with respect to the change from baseline on the clinically administered ADHD Rating Scale total score, with mean differences from placebo at week 4 of –8.1 (P < 0.001) for 12.5 mg and –13.3 (P < 0.001) for 37.5 mg. SHP465 12.5-mg and 37.5-mg doses were also significantly better than placebo on the key secondary efficacy analysis of the Clinical Global Impression–Improvement scale at week 4, with scores of –0.8 (P < 0.001) for 12.5 mg and –1.2 (P < 0.001) for 37.5 mg, suggesting a marked clinical improvement in the patients’ global functioning.
Treatment-emergent adverse events with either dose of SHP465 included decreased appetite, xerostomia, insomnia, headache, anxiety, irritability, and bruxism. Adverse events were generally mild-to-moderate in severity and similar to those with other amphetamine compounds.
Shire plans to file a class 2 resubmission of the new drug application for SHP465 by the end of 2016.
ADHD is a neurodevelopmental disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development and that is inconsistent with the developmental level. An estimated 4.4% of adults have ADHD in the U.S.
The specific etiology of ADHD is unknown. The diagnosis is made using criteria specified in the Diagnostic and Statistical Manual of Mental Disorders, fifth edition, or in the International Classification of Diseases, 10th revision. Only a trained health care professional can evaluate and diagnose ADHD.
Although there is no cure for ADHD, accepted treatments have been demonstrated to improve symptoms. Standard treatments include educational approaches and psychological therapies, which may include behavioral modification and/or medication. Ongoing assessment and treatment may be necessary.
Source: Shire; June 29, 2016.