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Shire Announces Positive Topline Results of SHP465 Efficacy and Safety Study in Adults with ADHD
- Source Link:
- https://www.shire.com/newsroom/2016/june/a5qnn5
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Additional Information
The primary efficacy analysis of study 306 showed that SHP465 12.5mg and 37.5mg, both administered as a daily morning dose, were superior to placebo with respect to the change from baseline on a clinically administered ADHD rating scale (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. SHP465 12.5mg and 37.5mg doses were also significantly better than placebo on the key secondary efficacy analysis of the clinical global impression improvement scale (CGI-I), 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), suggesting a marked clinical improvement in patients’ global functioning. The CGI-I is a standardized assessment tool that allows clinicians to rate the severity of ADHD illness, change over time and efficacy of medication.Treatment-emergent adverse events ≥ 5% for either dose of SHP465 were decreased appetite, dry mouth, insomnia, headache, anxiety, irritability and bruxism. Adverse events were generally mild to moderate in severity and similar to those observed in previous SHP465 studies and with other amphetamine compounds.
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Catalyst Date
Occurred on:
Jun 29, 2016
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Related Keywords
Shp465, Adhd, Positive Topline Results
