Triple-bead MAS: Phase III data

Top-line data from the double-blind, U.S. Phase III SHP465-306 trial in 275 ADHD patients ages 18-55 showed that once-daily 12.5 and 37.5 mg oral SHP465 each met the primary endpoint of improving ADHD-RS total score from baseline to week 4 vs. placebo (p<0.001 for both). Both doses of SHP465 also met the secondary endpoint of improving CGI-I score from baseline to week 4 vs. placebo (p<0.001 for both). Reduced appetite, dry mouth, insomnia, headache, anxiety irritability and bruxism were reported as the most common treatment-emergent adverse events. ...