PHILADELPHIA, Nov. 16 /PRNewswire-FirstCall/ -- Shire plc , the global specialty biopharmaceutical company, announced new study results on INTUNIV(TM) (guanfacine) Extended-Release Tablets published in the October Journal of Child and Adolescent Psychopharmacology. In this open-label safety study, there was no evidence of unique adverse effects with the combination of INTUNIV and amphetamine or methylphenidate relative to what was observed with either medication alone. The open-label study also assessed improvement of Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms using the ADHD Rating Scale-IV (ADHD-RS-IV). INTUNIV is a nonscheduled, once-daily selective alpha-2A agonist indicated for monotherapy treatment of ADHD in children and adolescents ages 6 to 17.
An estimated 25 to 30 percent of ADHD patients may not respond to the most commonly prescribed ADHD medications, methylphenidates and amphetamines, when used alone as ADHD treatment.
This nine-week, open-label, multicenter, dose-escalation study assessed the safety and effectiveness of coadministering INTUNIV with stimulant medications (methylphenidate or amphetamine). The enrolled patient population included 75 children and adolescents ages 6 to 17 diagnosed with ADHD whose ADHD symptoms were suboptimally controlled after at least one month of treatment with these stimulants. Investigators then started subjects at 1 mg/day of INTUNIV and increased the dose each week by 1 mg to the highest tolerated dose (1 mg/day, 2 mg/day, 3 mg/day, or 4 mg/day). Throughout the INTUNIV titration and maintenance phases of the study, subjects remained on the current dose of their stimulant medication.
Furthermore, coadministration of INTUNIV with methylphenidate or amphetamine did not increase sleepiness, as noted by the decrease in PDSS scores assessed at visit six and at the end of the study.
INTUNIV is not approved for coadministration with other ADHD medications.
Additional information about INTUNIV and Full Prescribing Information are available at www.intuniv.com
INTUNIV is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17. Efficacy was established in two controlled clinical trials (8 and 9 weeks in duration). The physician electing to use INTUNIV for extended periods should periodically reevaluate its long-term usefulness for the individual patient.
Hypotension, bradycardia, and syncope were observed in clinical trials. Use INTUNIV with caution in treating patients who have experienced hypotension, bradycardia, heart block, or syncope, or who may have a condition that predisposes them to syncope; are treated concomitantly with antihypertensives or other drugs that can reduce blood pressure or heart rate or increase the risk of syncope. Heart rate and blood pressure should be measured prior to initiation of therapy, following dose increases, and periodically while on therapy. Patients should be advised to avoid becoming dehydrated or overheated.
Common adverse reactions in patients taking INTUNIV that may be dose related over the range of 1 to 4 mg/day include somnolence, sedation, abdominal pain, dizziness, hypotension/decreased blood pressure, dry mouth, and constipation.
ADHD is one of the most common psychiatric disorders in children and adolescents. Worldwide prevalence of ADHD is estimated at 5.3 percent (with large variability), according to a comprehensive systematic review of this topic published in 2007 in the American Journal of Psychiatry. In the United States, approximately 7.8 percent of all school-aged children, or about 4.4 million children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the Centers for Disease Control and Prevention (CDC).
Although there is no cure for ADHD, there are accepted treatments that specifically target its symptoms. Standard treatments include educational approaches, psychological or behavioral modification, and/or medication.
ADHD-RS-IV is a standardized, validated test for assessing symptoms of ADHD and for assessing response to treatment. The scale, which contains 18 items, is based on the ADHD diagnostic criteria as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision(R), a publication of the American Psychiatric Association.
CHQ-PF50 is a validated quality-of-life measure currently used in pediatric studies. In this measure, the parent answered questions that assessed 14 core health concepts, and resulted in 2 summary scores: one for the subject’s physical well-being and another for the subject’s psychosocial well-being. The transformed scores ranged from 0 to 100, with higher scores indicative of improved health.
PDSS is a self-rated assessment of daytime sleepiness that was completed at screening, baseline, and visits 1 through 9. The subjects responded to 8 questions related to sleepiness using a Likert scale rating (never = 0; always = 4). Higher scores on the PDSS indicated greater levels of sleepiness.
PSERS is a clinician-rated scale used to assess the severity of AEs such as dullness, tiredness, listlessness, headache, stomach ache, loss of appetite, and trouble sleeping. The PSERS was completed at screening and visits 1 through 9. Severity of AEs was rated as none, mild, moderate, or severe.
Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire’s in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.
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