Shire plc today announced that VYVANSE™ (lisdexamfetamine dimesylate) effectively controlled Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in children aged 6 to 12 years. In addition, 95 percent of children taking VYVANSE daily for 12 months showed overall improvement, according to phase III open-label extension trial results. Further analysis of phase II clinical data demonstrated that VYVANSE provided consistent time to maximum concentration of d-amphetamine from patient to patient. Both studies were presented today at the annual meeting of the American Psychiatric Association (APA).

The U.S. Food and Drug Administration (FDA) approved VYVANSE for the treatment of ADHD on Feb. 23, 2007. VYVANSE remains on track for commercial launch in June 2007.

"Our research concluded that patients taking a daily morning dose of VYVANSE for up to 12 months demonstrated consistent control in ADHD symptoms from month to month," said Robert Findling, M.D., lead investigator of the long-term open-label study and Professor of Psychiatry at Case Western Reserve University and Director of the Division of Adolescent and Child Psychiatry at University Hospitals Case Medical Center. "As the first prodrug stimulant, VYVANSE will provide a novel approach to the delivery of stimulant medication for the treatment of ADHD."

Long-term Treatment with VYVANSE Yields Significant ADHD Symptom Improvement

In the long-term open-label extension trial, patients taking VYVANSE showed a greater than 60 percent improvement in the symptoms of ADHD, based on the participants' average change in ADHD Rating Scale (ADHD-RS-IV) scores* from baseline, the primary endpoint, after one year of treatment. Specifically, mean scores decreased 63 percent from baseline (P <.0001). Additionally, 95 percent of patients who received 12 months of daily treatment were rated as "very much improved" or "much improved" by physicians on the Clinical Global Impressions-Improvement (CGI-I) scale, a secondary endpoint.

All 272 patients in the long-term trial previously participated in either of two double-blind clinical trials of VYVANSE. In the long-term trial, investigators provided participants with 30 mg once-daily doses of VYVANSE for one week, and then adjusted the dosage by 20 mg at weekly intervals during three subsequent visits to achieve optimal efficacy and tolerability. Participants continued treatment for the remaining 11 months. The maximum daily dose was 70 mg.

Safety was also evaluated during the study and VYVANSE was generally well tolerated. Most treatment-associated adverse events were mild to moderate in severity, occurred during the first eight weeks of treatment and incidence decreased over time. The most frequently reported adverse events in this trial were decreased appetite, headache, decreased weight and insomnia.

VYVANSE Demonstrated Consistent Time to Maximum Concentration of d-amphetamine from Patient to Patient

A once-daily 70 mg dose of VYVANSE provided low variability in the time from administration to maximum concentration of d-amphetamine from patient to patient. This finding was based on data from 17 children with ADHD aged 6 to 12 years enrolled in a double-blind phase II crossover trial examining the efficacy and safety of VYVANSE and mixed amphetamine salts extended release (MAS XR) in comparison to placebo.

Patients taking VYVANSE achieved maximum d-amphetamine concentration within a narrow time window of 4.5 to 6 hours. Patients taking MAS XR achieved maximum d-amphetamine concentration between 3 to 12 hours.

*ADHD-RS-IV is a standardized, validated test for assessing symptoms of ADHD in children and for assessing their 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®, a publication of the American Psychiatric Association. The CGI-I also is a standard assessment tool and rates the severity of a patient's illness, improvement over time and efficacy of medication.

About ADHD

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. 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.

Source: Porter Novelli