Results Of Vyvanse (lisdexamfetamine dimesylate) Effect Size Analysis Presented at Major Scientific Meeting
BOSTON, Oct. 26 /PRNewswire-FirstCall/ -- Shire plc , the global specialty biopharmaceutical company, today announced results from an analysis of Vyvanse (lisdexamfetamine dimesylate) effect size. These findings were presented today at a national meeting of psychiatrists in Boston. Effect size is a standardized and scientific method of comparing effectiveness of medications evaluated in different studies for the same condition. In general, effect sizes are categorized as small (0.2), medium (0.5) and large (0.8).
An analysis of the phase III pivotal study in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD) showed the effect size of VYVANSE was 1.39, 1.42 and 1.73 for 30 mg, 50 mg and 70 mg, respectively. This analysis was conducted to establish that the effect size of VYVANSE was due to the medication's effectiveness and not due to two potential influencing factors: the precision of measurement as indexed by standard deviation of endpoint scores, and the size of baseline versus endpoint placebo effect. The findings show that neither of these factors played a role in determining the effect size of VYVANSE. The relationship between effect size and clinical benefit has not been established.
"I'm encouraged that in our analysis, VYVANSE showed a large effect size," said Stephen Faraone, Ph.D., director of medical genetics research and head of child and adolescent psychiatry research at SUNY Upstate Medical University, who led the analysis. "This further supports our belief that VYVANSE is an effective treatment option for children with ADHD."
VYVANSE is a prodrug of d-amphetamine and is approved in the U.S. for the treatment of ADHD in children aged 6 to 12 years.
Approximately 7.8 percent of all school-age children, or about 4.4 million U.S. children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the CDC. ADHD is one of the most common psychiatric disorders in children and adolescents. The disorder is also estimated to affect 8.1 percent of adults, or approximately 9.2 million adults across the U.S. based on a retrospective survey of adults aged 18 to 44, projected to the full U.S. adult population. ADHD is a neurological brain disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development. To be properly diagnosed with ADHD, a child needs to demonstrate at least six of nine symptoms of inattention; and/or at least six of nine symptoms of hyperactivity/impulsivity; the onset of which appears before age 7 years; that some impairment from the symptoms is present in two or more settings (e.g., at school and home); that the symptoms continue for at least six months; and that there is clinically significant impairment in social, academic or occupational functioning and the symptoms cannot be better explained by another psychiatric disorder.
Although there is no "cure" for ADHD, there are accepted treatments that specifically target its symptoms. The most common standard treatments include educational approaches, psychological or behavioral modification, and medication.
For further information on ADHD please visit: www.ADHDSupport.com POSTER INFORMATION Lisdexamfetamine Dimesylate Effect Size in Children with Attention- Deficit/Hyperactivity Disorder October 26, 2007, 2007; 3:30 p.m. EDT
Tell the doctor about any heart conditions, including structural abnormalities, that you, your child, or a family member, may have. Inform the doctor immediately if your child develops symptoms that suggest heart problems, such as chest pain or fainting.
VYVANSE should not be taken if your child has advanced disease of the blood vessels (arteriosclerosis); symptomatic heart disease; moderate to severe high blood pressure; overactive thyroid gland (hyperthyroidism); known allergy or unusual reactions to drugs called sympathomimetic amines (for example, pseudoephedrine); seizures; glaucoma; a history of problems with alcohol or drugs; agitated states; taken a monoamine oxidase inhibitor (MAOI) within the last 14 days.
Tell the doctor before taking VYVANSE if your child is being treated for or has symptoms of depression (sadness, worthlessness, or hopelessness) or bipolar disorder; has abnormal thought or visions, hears abnormal sounds, or has been diagnosed with psychosis; has had seizures or abnormal EEGs; has or has had high blood pressure; exhibits aggressive behavior or hostility. Tell the doctor immediately if your child develops any of these conditions or symptoms while taking VYVANSE.
Abuse of amphetamines may lead to dependence. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events. These events have also been reported rarely with amphetamine use.
VYVANSE was generally well tolerated in clinical studies. The most common side effects reported in studies of VYVANSE were decreased appetite, difficulty falling asleep, stomachache, and irritability.
Aggression, new abnormal thoughts/behaviors, mania, growth suppression, worsening of motion or verbal tics, and Tourette's syndrome have been associated with use of drugs of this type. Tell the doctor if your child has blurred vision while taking VYVANSE.
For more information about VYVANSE, visit www.vyvanse.com.
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 and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe. Shire believes that a carefully selected portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.
For further information on Shire, please visit the Company's website: www.shire.com
THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward- looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research; product development including, but not limited to, the successful development of JUVISTA(R) (Human TGFb3) and GA GCB (velaglucerase alfa); manufacturing and commercialization including, but not limited to, the launch and establishment in the market of VYVANSE(TM) (Attention Deficit and Hyperactivity Disorder ("ADHD"); the impact of competitive products including, but not limited to, the impact of those on Shire's ADHD franchise; patents including, but not limited to, legal challenges relating to Shire's ADHD franchise; government regulation and approval including, but not limited to, the expected product approval date of INTUNIV(TM) (guanfacine extended release) (ADHD); Shire's ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire plc's filings with the Securities and Exchange Commission, particularly Shire plc's Annual Report on Form 10-K for the year ended December 31, 2006.
CONTACT: Jacelyn Seng, +1-212-601-8385, on site at meeting, +1-917-392-0756, Brooke Salti, +1-212-601-8241, on site at meeting, +1-646-761-5824,both of Porter Novelli for Shire
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Posted: October 2007