Biopharmaceutical company Shire Plc (SHPGY, SHP.L, SHPGF) said Monday that results from an open-label study did not show any evidence of unique adverse effects with the combination of Intuniv extended-release tablets and amphetamine or methylphenidate. The findings are relative to what was observed with either amphetamine or methylphenidate alone in treatment of adolescents of ages between 6 to 17 with Attention-Deficit/Hyperactivity Disorder.
Andrew Cutler said, "Pivotal studies have shown that Intuniv improved ADHD symptoms in children and adolescents with the disorder, and the publication of these safety data gives us insight into administering Intuniv in combination with stimulant medications in the management of ADHD."
Andrew Cutler is courtesy assistant professor, department of psychiatry, University of Florida, and CEO and medical director, Florida Clinical Research Center, Bradenton, Florida.
In the nine-week, open-label, multicenter, dose-escalation study for assessment of the safety and effectiveness of co-administering of Intuniv with stimulant medications showed fatigue as the most common adverse effect with 34.7%, headache was found in 33.3% of the total population under the study, upper abdominal pain in 32% of the patients. The other adverse effects reported were somnolence and insomnia.
The investigators deemed that Intuniv related adverse effects were upper abdominal pain in 25.3% of the population, fatigue in 24% of the patients and headache in 20% of the study population. Further, somnolence was found in 18.7% of the population and insomnia in 13.3% of the patients.
Intuniv is a nonscheduled, once-daily selective alpha-2A agonist indicated for monotherapy treatment of ADHD. Intuniv is currently not approved for co-administration with other ADHD medications.
While treating ADHD, an estimated 25 to 30% of ADHD patients may not respond to the most commonly prescribed ADHD medications, methylphenidates and amphetamines, when used alone, the company noted.
The study met its primary objective which was to evaluate the safety of co-administration of Intuniv up to 4 milligram per day with stimulants.
SHPGY is currently trading at $58.14, down $1.67 or 2.80% on Nasdaq and SHP closed at its regluar trading session on Monday at 1,155 pence, up 7 pence or 0.61% on LSE.
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