SHP465-306 safe, effective for adult ADHD

SHP465-306, a triple-bead mixed amphetamine salts capsule from Shire, was effective and safe for attention-deficit/hyperactivity disorder, according to recent findings.

Safety and efficacy of the ADHD treatment was assessed in a 4-week, randomized, double-blind, multicenter, parallel-group, placebo-controlled, forced-dose titration study among 275 adults aged 18 to 55 years with ADHD. Study participants received 12.5 mg or 37.5 mg of SHP465-306 or placebo as a daily morning dose.

At week 4, least square mean differences in ADHD Rating Scale total scores were –8.1 (95% CI, –11.7 to –4.4; P < .001) among participants who received 12.5 mg of SHP465-306 and –13.3 (95% CI, –17 to –9.6; P < .001) among those who received 37.5 mg of SHP465-306, compared with placebo.

Least square mean differences in Clinical Global Impression Improvement Scale scores were –0.8 (95% CI, –1.1 to –0.4; P < .001) among participants who received 12.5 mg of SHP465-306 and –1.2 (95% CI, –1.6 to –0.9; P < .001) among those who received 37.5 mg of SHP465-306, compared with placebo.

Treatment-emergent adverse events that occurred in more than 5% of participants receiving SHP465-306 were decreased appetite, dry mouth, insomnia, headache, anxiety, irritability and bruxism.

Adverse events were generally mild to moderate, according to researchers.

“ADHD affects adults in multiple ways and, therefore, physicians need additional treatment options. Based upon this study’s findings, and pending the U.S. FDA’s review, SHP465 may provide a promising treatment option for physicians and patients alike,” study researcher Matthew Brams, MD, of Baylor College of Medicine, said in a press release.