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Shire Announces Preliminary Results of Largest Adult ADHD Trial Conducted to Date

Qu.E.S.T. Study Presented at Children and Adults with Attention-Deficit/Hyperactivity Disorder Annual Meeting

DALLAS, TX -- October 28, 2005 -- Shire Pharmaceuticals Inc. presented new data demonstrating that Adderall XR(R) (mixed salts of a single-entity amphetamine product) significantly improves symptoms in adults with Attention- Deficit/Hyperactivity Disorder (ADHD).

Nearly 75% of study participants experienced improvement in ADHD symptoms, according to preliminary results of the Quality of Life, Effectiveness, Safety, and Tolerability (Qu.E.S.T.) study, presented today at the annual meeting of Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD).

"Qu.E.S.T. is the largest study of its kind to date to document improvements in symptoms of adult ADHD," said Qu.E.S.T. investigator David Goodman, MD, Director, Adult Attention Deficit Disorder Center of Maryland, Lutherville, Md. "The good news for adults with ADHD is that Adderall XR was shown to improve ADHD symptoms and was also generally well tolerated."

Qu.E.S.T. is a 30-week, open-label, multicenter investigation of adults, aged 18 and older, diagnosed with ADHD who receive treatment with once-daily Adderall XR, dosed at 10 mg to 60 mg daily (the recommended dose for adult patients is 20 mg per day).

This study was conducted in community practice settings at 74 U.S. and seven Canadian sites. The results from this interim analysis, presented at CHADD, focus on data collected on 702 patients who completed a core 10-week phase.

Qu.E.S.T. Study Results
In this study, ADHD symptom improvement was measured using the ADHD Rating Scale Version IV (ADHD-RS-IV) and Clinical Global Impression-Improvement scale (CGI-I). Both are validated clinician rating scales.

The results for the intent-to-treat population (702 patients) indicated that ADHD-RS-IV total scores were significantly improved by approximately 60% (-19.8 unit points) at end point of the core 10-week phase, (P <.0001). Results for the ADHD-RS-IV hyperactivity/impulsivity and inattentiveness subscale scores were similar to the results for the total score and demonstrated significant symptom improvement for hyperactivity/impulsivity (-8.1 points, P <.0001) and inattentiveness (-11.6 points, P <.0001).

Previous treatment status did not influence patient outcomes. Improvement in ADHD-RS-IV scores at the end of 10 weeks was comparable among the 378 patients who had no previous ADHD medication treatment (-20.2 points), 272 patients with previous stimulant treatment (-18.8 points) and 52 patients with previous nonstimulant treatment (-21.6 points).

Significant decreases of similar size occurred among the three treatment groups in the ADHD-RS-IV hyperactivity/impulsivity and inattentiveness subscores (all P <.0001). Additionally, 74.4% of these 702 patients experienced improvement in ADHD symptoms (characterized as much or very much improved) after 10 weeks of Adderall XR treatment, as measured by the CGI-I.

In this study, Adderall XR was generally well tolerated. The most commonly reported drug-related adverse events in Qu.E.S.T. were generally mild and included decreased appetite, headache, dry mouth and insomnia. The most common adverse events contributing to study discontinuation were increased heart rate (1.4%), elevated blood pressure (0.8%) and insomnia (0.8%). At the end of 10 weeks of treatment, minimal changes in pulse rates (5.2 beats per minute), systolic blood pressure (0.9 mm Hg) and diastolic blood pressure (1.4 mm Hg) were observed, but none were judged to be clinically significant by the investigators.

An additional analysis of quality of life showed that patients had improvement in 35 of 36 quality of life measures, as determined with a standard, validated tool, the Short Form Health Survey, version 2 (SF-36v2), (P <.0001). The exception was the improvement for bodily pain, (P=0.14), which had not been expected to improve with ADHD therapy.

Additional Study Information
During the 10-week study period, investigators gave patients 20 mg once- daily doses of Adderall XR during the first week. Based on the investigators' judgment, they adjusted doses to achieve optimal therapeutic response and tolerability in increments of 10 mg per day to a maximum dose of 60 mg daily. In adults with ADHD, the recommended dose is 20 mg per day.

Adult patients participating in this study averaged 38 years old, 55% were female and 90% were Caucasian. All patients met the ADHD diagnosis criteria as defined in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR(R)). Of those enrolled, 57% were diagnosed with ADHD combined subtype and 40%, inattentive subtype.

About ADHD
ADHD affects approximately 7.8% of all school-age children, about 4.4 million U.S. children aged 4 to 17 years, according to the U.S. Centers for Disease Control and Prevention. Up to 80% of children with ADHD may continue to experience symptoms into adolescence and up to 65% may continue to experience symptoms into adulthood. Approximately eight million American adults currently struggle with the symptoms of ADHD.

ADHD is a neurological behavioral disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than typically observed in individuals at a comparable age and maturity level. Because everyone shows signs of these behaviors at times, the behaviors must appear early in life (before age 7) and continue for at least six months, according to the ADHD diagnosis criteria as defined in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR(R)).

Although there is no cure for ADHD, physicians and advocates are finding ways to help people with the condition learn to adapt to their school, home, social and work settings. ADHD usually can be successfully managed with a combination of treatments, such as behavioral therapy, skill building and medication. Medication should be considered part of an overall multi-modal treatment plan for ADHD.

About Adderall XR
Adderall XR was generally well tolerated in clinical studies. The most common side effects in studies included: children -- decreased appetite, difficulty falling asleep, stomachache, and emotional lability; adolescents -- loss of appetite, difficulty falling asleep, stomachache, and weight loss; adults -- dry mouth, loss of appetite, difficulty falling asleep, headache, and weight loss.

Adderall XR may not be right for everyone. Patients should speak with their doctor if they have a history of high blood pressure or any heart conditions, glaucoma, thyroid problems, emotional instability, mental illness, or a known allergy to this type of medication. Abuse of amphetamines may lead to dependence. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events. These events have also been reported rarely with amphetamine use.

If you are currently taking or have recently taken a type of antidepressant called a MAO inhibitor or have a pre-existing structural heart abnormality, you should not take Adderall XR. There is a potential for worsening of motion or verbal tics and Tourette's syndrome. A patient should report any new psychological symptoms to his or her physician.


SOURCE: Shire Pharmaceuticals Inc.

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