Published Results Also Show Potentially Differentiating Pharmacokinetic
Profile of Prodrug Stimulant
PHILADELPHIA, Nov. 29 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY, TSX: SHQ), the global specialty biopharmaceutical company, today announced that Biological Psychiatry published the results of a study showing VYVANSE(TM) (lisdexamfetamine dimesylate), the first prodrug stimulant for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), provided significant efficacy in children for up to 12 hours. The published study also found that VYVANSE demonstrated low interpatient variability of measured pharmacokinetic parameters, as reported by the coefficient of variance (%CV).
This phase II randomized, double-blind, placebo- and active-controlled crossover analog classroom study in children aged 6 to 12 examined the efficacy and safety of VYVANSE (30 mg, 50 mg or 70 mg) and Adderall XR (mixed amphetamine salts extended-release: 10 mg, 20 mg or 30 mg) compared with placebo.
"This newly published research shows that VYVANSE provided a consistent time to maximum plasma concentration from patient to patient," said Ann S. Childress, M.D., President of the Center for Psychiatry and Behavioral Medicine, Inc. in Las Vegas, Nev. "This prodrug stimulant also demonstrated significant efficacy up to 12 hours after administration, which is something that my patients' parents are interested in as it may help to improve their family and homework time in the evening."
VYVANSE is a therapeutically inactive prodrug in which d-amphetamine is covalently bonded to l-lysine, and after oral ingestion it is converted to pharmacologically active d-amphetamine. Release of the active ingredient in VYVANSE does not rely on gastrointestinal factors such as gastrointestinal transit time and gastric pH.
Study Results Showed that VYVANSE Demonstrated Significant Efficacy for Treatment of ADHD for up to 12 Hours
VYVANSE demonstrated significant efficacy for treatment of ADHD for up to 12 hours post dosing, based on the study's primary efficacy measure, SKAMP-D. Investigators observed a significant difference in patient behavior based upon the average of investigator ratings on the Swanson, Kotkin, Agler, M-Flynn and Pelham Rating Scale deportment (SKAMP-D) scores across eight classroom sessions held during a 12-hour treatment day between patients who received VYVANSE and patients who received Adderall XR, both compared to placebo. The SKAMP-D is a standardized, validated classroom assessment tool used for evaluating the behavioral symptoms of ADHD and higher SKAMP-D ratings reflect greater impairment.
Patients in the study taking VYVANSE also demonstrated significant improvement in math problems attempted as compared to placebo, as measured by the Permanent Product Measure of Performance (PERMP) Derived Measures. When patients were observed at the 12-hour time period, the LS mean change in PERMP math problems attempted from the first measurement was 49 for patients taking VYVANSE and 22 for patients taking Adderall XR, compared to -24 for placebo. PERMP is an age-adjusted collection of math problems that provides an objective measure of performance based on the number of attempted and completed math problems. This study was not designed as a comparative trial between active treatments.
Low Interpatient Variability Demonstrated
In this study, pharmacokinetic parameters were also measured, which found that the coefficient of variance for time to maximum drug concentration for VYVANSE and Adderall XR were 15.33 and 52.77, respectively. The coefficient of variance is a measure used to determine how much variance there is in the data, with smaller numbers indicating less variability. The coefficient of variance of maximum observed drug concentration for VYVANSE and Adderall XR were 20.34 and 43.96, respectively. The relationship between pharmacokinetics and clinical benefit has not been established.
The majority of adverse events reported in this study were mild to moderate in severity. The most frequently reported adverse events for VYVANSE were insomnia (8 percent), decreased appetite (6 percent), anorexia (4 percent) and upper respiratory tract infection (2 percent); for Adderall XR they were decreased appetite (4 percent), upper abdominal pain (4 percent), insomnia (2 percent), upper respiratory tract infection (2 percent) and vomiting (2 percent).
VYVANSE is currently approved in the United States for the treatment of ADHD in children aged 6 to 12 years.
Additional information about VYVANSE and Full Prescribing Information are available at http://www.vyvanse.com.
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 U.S. Centers for Disease Control and Prevention (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 neurobiological 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.
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.
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 Web site: http://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 TGFbeta3) and GA-GCB (velaglucerase alfa); manufacturing and commercialization including, but not limited to, the launch and establishment in the market of VYVANSE(TM) (lisdexamfetamine dimesylate) (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.
|SOURCE Shire plc|
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