Drug maker Shire Plc (SHPGY, SHP.L), Thursday reported positive findings from its Vyvanse late-stage trials, indicating the drug significantly improved frequent changes in emotions or mood, known as Emotional Lability, in children with Attention-Deficit/Hyperactivity Disorder or ADHD.
In the post hoc analysis, where researchers look into test results for patterns that were not specified, average emotional lability of the children significantly improved with Vyvanse treatment compared with placebo.
Shire earlier conducted Phase III trails with forced-dose escalation in 30, 50, or 70 mg/d of Vyvanse in children aged 6 to 12 years with ADHD. The study demonstrated significant improvement in symptoms as measured by the ADHD Rating Scale .
"Children taking ADHD medications can experience emotional lability, often described as frequent changes in emotions or mood," said the company, justifying the importance of the post hoc analysis of the late-stage trials.
Overall, the treatment with Vyvanse improved emotional lability scores across the day from study start to end among patients, compared to placebo.
However, only those children with prominent emotional lability before treatment showed considerable statistical significance, while those who enrolled without prominent emotional lability did not report any significant improvements after treatment with Vyvanse.
The most common treatment-emergent adverse events in the study with Vyvanse were decreased appetite, insomnia, upper abdominal pain, headache, irritability, vomiting, weight decrease, nausea, dizziness, and dry mouth.
Vyvanse was introduced in the U.S. in July 2007 for the treatment of ADHD in children aged 6 to 12 years and approved in April 2008 to treat ADHD in adults.
The drug leads Shire's product portfolio in net sales, yielding US $129 million for the recently ended third quarter, reflecting a 34% year-on-year increase in net sales. The UK based company's share of the total U.S. ADHD market for the three months to September 30, 2009 was 22%.
The company also plans to launch the blockbuster drug in ex-US and ex-EU regions starting in 2010, and in the EU in2011. Its 'to-be-launched' portfolio includes yet another ADHD cure Intuniv for children to be available in the US in November 2009.
SHPGY is currently trading at US$56.48, down 0.34%, on 221 thousand shares on the Nasdaq. SHP.L closed Thursday's regular trading sessions at 1,132.00 pence, down 8.00 pence.
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