ADHD kids quality of life significantly improves with long-term, once-daily Adderall XR

May 21, 2003

Quality of life in children with ADHD significantly improves with long-term, once-daily use of a once-daily mixed salts amphetamine product

San Francisco, CA, May 21, 2003 - Shire Pharmaceuticals Group plc (NASDAQ: SHPGY, LSE: SHP.L, TSE: SHQ CN) announced results from a clinical trial demonstrating that children with attention-deficit/hyperactivity disorder (ADHD) experienced significant quality of life improvements and ADHD symptom control, when treated with a regimen that included once-daily mixed salts amphetamine product. Data from the largest ADHD clinical trial conducted to date, involving more than 2,900 patients, were presented on May 21, 2003 at the American Psychiatric Association (APA) annual meeting.

ADHD is the most commonly diagnosed psychiatric disorder in children and adolescents. Approximately two million U.S. children, 3 to 7 percent of all school-aged children, have been diagnosed with ADHD. The symptoms of ADHD have a profound effect on a child's quality of life and can be serious enough to interfere beyond academics. Children with ADHD may also have problems maintaining friendships, focusing on sports and other after-school activities and relating well within their own families.

"This largest study ever of ADHD patients establishes the significant improvements that treatment with the once-daily mixed salts amphetamine medication brings in decreasing symptoms. Such symptom control allows children to functionally improve and participate in life, such as engage in sports, get along with other kids, or help with chores," said Paul J. Ambrosini, M.D., professor of psychiatry at Drexel University College of Medicine in Philadelphia, Pa., and lead investigator of the study, known as Long-acting ADDerall Community Assessment Trial (LADD.CAT).

An Open-Label Community Assessment Trial of a Once-Daily Mixed Salts Amphetamine Product: Quality of Life Assessments (APA Presentation Session #21)
Children in the LADD.CAT trial previously were taking either mixed salts amphetamine product, methylphenidate HCl or another methylphenidate product, and switched to once-daily mixed salts amphetamine product. Results demonstrated significant improvement in participant's quality of life, as measured on the 23-item Pediatric Quality of Life InventoryTM (PedsQLTM), a validated health-related assessment tool designed to measure four health dimensions outlined by the World Health Organization: physical, emotional, social and school functioning. Parents were asked, among other questions, regarding the previous month, how much of a problem their child had with:Higher scores on the PedsQL indicate an improvement in quality of life. In the study, the patients had significant increases (6.5 percent) in their total PedsQL score (P <0.00001), meaning that the problems the children faced were almost never occurring or moving closer to never occurring. When any influence for dose titration or modification was eliminated, improvement was nearly identical (5.8 percent) and also significant (P < 0.00001).

"These improvements in patients' quality of life show the reality of what effective ADHD symptom management means to a child and their family," said investigator Floyd R. Sallee, M.D., professor of psychiatry and pediatrics at the Cincinnati Children's Hospital Medical Center in Ohio. "These children are able to better interact with other children and adults, concentrate in school and focus on finishing tasks."

When using the PedsQL physical subscale, investigators documented significant improvement, as measured by the patient's ability to participate in activities such as sports or exercise, taking a bath or shower by themselves, and doing chores around the house. In this study, patients had significant improvements (4.4 percent) in scores on the physical subscale (P <0.00001). When any influences for dose titration or modification were eliminated the improvements were nearly identical (4.0 percent, P < 0.00001).

To measure the patients' emotional, social and school functioning, Sallee and his colleagues used the PedsQL psychosocial subscale, which measures, for example, whether patients feel fear, sadness or anger, or have trouble sleeping or getting along with other children, and if they experience teasing, keep up at play or with schoolwork, pay attention in class and forget things. In the study, patients had significant improvement in scores (7.9 percent) on the psychosocial subscale (P <0.00001). Again, when any influences for dose titration or modification were eliminated, the improvements were nearly identical at (6.9 percent, P < 0.00001).

An Open-Label Community Assessment Trial of a Once-Daily Mixed Salts Amphetamine Product in Pediatric ADHD (APA Presentation Session #21) Further results from this trial showed that in addition to marked improvements in quality of life, a regimen containing a once-daily mixed salts amphetamine product significantly improved ADHD-associated symptoms, as measured both at eight and 12 hours. This improvement was maintained throughout the seven-week study.

For the primary efficacy assessment, parents completed the Conners' Global Index Scale-Parent Version (CGIS-P), at eight and 12 hours after the morning daily dose of medication. This validated 10-item scale is sensitive to treatment response and medication effectiveness. CGIS-P total scores range from zero to 30, with lower scores being associated with a decreased prevalence of ADHD symptoms. At study end, participant's scores declined, indicating improvement in symptom control. Participants averaged eight-hour scores of 5.4 and 12-hour scores of 7.4, which were significantly better than their baseline score of 10.2 (P < 0.0001).

Importantly, even when any influence of dose titration was eliminated, significant improvement in symptom control was also seen.

LADD.CAT was a seven-week prospective, open-label, community assessment trial that included over 2,900 children with ADHD who had previously been treated with a stable dose of ADHD medication, either methylphenidate HCl), another methylphenidate product or a mixed salts amphetamine product. Investigators switched the patients' medication to once-daily mixed salts amphetamine product the morning after their initial LADD.CAT visit using strict criteria and calculations to approximate equivalent therapeutic potency between the previous treatment and the study drug. At study weeks one and three, investigators could adjust, or titrate, the dose if necessary based on efficacy assessments or because of spontaneously reported adverse side effects. The majority of participants received 20-milligram (mg) doses of the study drug, but others received 10, 30 or 40 mg daily doses. The participants averaged in age 9.5 years, 76 percent were boys, 88 percent were white and 7 percent were black.

The once daily mixed salts amphetamine product was generally well tolerated during LADD.CAT. The majority of treatment-emergent side effects were mild or moderate and similar to those seen in previous clinical trials of the drug. Of the 2,986 patients who enrolled in the trial, only 5.1 percent discontinued their participation because of treatment-emergent side effects.

About ADHD
Approximately two million U.S. children, 3 to 7 percent of all school-aged children, have been diagnosed with ADHD and as many as 66 percent may still exhibit symptoms into adulthood, according to the National Institute of Mental Health. ADHD is a significant mental health concern that impacts the patients, their families and their social circles. Children with ADHD often are inattentive, impulsive, and hyperactive - difficulties serious enough to interfere with their ability to function normally in home, academic or social settings. These symptoms continue beyond the school day, affecting all aspects of the child's life.

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. Hyperactivity is seen less frequently as the patient ages, however, inattention and impulsivity often remain.

Although there is no "cure" for ADHD, physicians, parents, teachers, nurses and advocates are finding ways to help people with the condition learn to adapt to their academic, social and work settings. ADHD usually can be successfully managed with a combination of treatments, including educational approaches, psychological and behavioral therapies and medication. Medication should be considered part of an overall multi-modal treatment plan for ADHD.
Shire Pharmaceuticals Group plc
Shire Pharmaceuticals Group plc (Shire) is a rapidly growing international emerging pharmaceutical company with a strategic focus on four therapeutic areas - central nervous system disorders (CNS), gastrointestinal (GI), oncology, and anti-infectives. Shire also has three platform technologies: advanced drug delivery, lead optimization for small molecules and Biologics. Shire's core strategy is based on research and development combined with in-licensing and a focus on eight key pharmaceutical markets.

The once daily mixed salts amphetamine product is distributed in the United States by Shire US Inc., the sales and marketing subsidiary of Shire Pharmaceuticals plc.

For further information on Shire, please visit the Company's website:; or

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, manufacturing and commercialization, the impact of competitive products, including, but not limited to, the impact on Shire's Attention Deficit Hyperactivity Disorder (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 lanthanum carbonate (FOSRENOL®) and METHYPATCH ®, and other risks and uncertainties detailed from time to time in our filings, including the Annual Report filed on Form 10-K by Shire with the Securities and Exchange Commission.

APA Presentation Session #21,Wednesday, May 21, 2003; 11 - 12:30 PM
An Open-Label, Community Assessment Trial of Adderall XR in Children With ADHD Quality of Life Results

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