Shire announced positive topline results from the efficacy and safety study of SHP465 (triple-bead mixed amphetamine salts – MAS) for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults.

SHP465-306 is a four-week, randomized, double-blind, multicenter, parallel-group, placebo-controlled, forced-dose titration study evaluating the efficacy and safety of daily morning dose of SHP465 12.5mg and 37.5mg in 275 adults aged 18–55 years with ADHD. The primary efficacy endpoint was change from baseline on a clinically administered ADHD rating scale (ADHD-RS) total score. Key secondary endpoint included the clinical global impression improvement scale (CGI-I) score, a standardized assessment tool that allows clinicians to rate the severity of ADHD illness, change over time and efficacy of medication. 

Results from the study showed that both doses of SHP465 were superior to placebo with respect to the change from baseline on ADHD-RS total score, with Least Squares mean differences from placebo at Week 4 of –8.1 (95% CI: –11.7 to –4.4, P<0.001) for 12.5mg, and –13.3 (95% CI: –17.0 to –9.6, P<0.001) for 37.5mg. Both doses also demonstrated a significant clinical improvement over placebo in the patients’ global functioning, with a CGI-I scale score at Week 4 of –0.8 (95% CI: –1.1 to –0.4, P<0.001) for 12.5mg, and –1.2 (95% CI: –1.6 to –0.9, P<0.001) for 37.5mg. The most common treatment-emergent adverse events for SHP465 were decreased appetite, dry mouth, insomnia, headache, anxiety, irritability and bruxism.

Shire intends to file a Class 2 Resubmission of the New Drug Application (NDA) for SHP465 to the FDA by the end of 2016, with a potential approval in the second half of 2017.

SHP465 (triple-bead mixed amphetamine salts) is an investigational oral stimulant.

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