Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, has announced that it will present key scientific data on its Attention Deficit Hyperactivity Disorder (ADHD) treatments lisdexamfetamine dimesylate (CII) and investigational non-scheduled guanfacine extended release, at a national scientific meeting of psychiatrists being held May 16 -21 in San Francisco, CA.

“Shire is committed to the advancement of ADHD treatment research and eager to present results from a spectrum of studies,” said Jeffrey Jonas, MD, Senior Vice President of Research & Development for the Specialty Pharmaceuticals business at Shire. “We believe the lisdexamfetamine dimesylate and guanfacine extended release study findings to be presented will contribute greatly to the growing body of research and development for physicians in the field of ADHD.”

A summary of the key scientific presentations is provided below:

Lisdexamfetamine Dimesylate
May 18, 2009
Pharmacokinetics of Intranasal Versus Oral Administration of Lisdexamfetamine Dimesylate in Healthy Adults
Poster Presentation #NR2-027

May 18, 2009
Duration of Effects of Lisdexamfetamine Dimesylate on Behavior of Children With Attention-Deficit/Hyperactivity Disorder in Naturalistic Settings
Poster Presentation # NR2-029

May 18, 2009
Patient Experience and Satisfaction with Lisdexamfetamine Dimesylate in Adults With ADHD
Poster Presentation #NR2-020

May 18, 2009
Response and Symptomatic Remission in a Long-Term Trial of Lisdexamfetamine Dimesylate in Adults with Attention-Deficit/Hyperactivity Disorder
Poster Presentation #NR2-054

May 18, 2009
Improvement in Emotional Expression in Children with Attention-Deficit/Hyperactivity Disorder Treated with 20 to 70 mg/day Lisdexamfetamine Dimesylate
Poster Presentation #NR2-019

May 18, 2009
Improvement in Executive Function in Children with Attention-Deficit/Hyperactivity Disorder Treated With 20 to 70 mg/Day Lisdexamfetamine Dimesylate
Poster Presentation #NR2-051

May 18, 2009
Changes in Emotional Expression Related to Medication Used to Treat Attention-Deficit/Hyperactivity Disorder
Poster Presentation #NR2-038

Guanfacine Extended Release
May 18, 2009
Effects of Guanfacine Extended Release on Secondary Measures in Children With Attention-Deficit/Hyperactivity Disorder and Oppositional Symptoms
Poster Presentation #NR2-060

About VYVANSE

Vyvanse is indicated for the treatment of ADHD. Efficacy based on two controlled trials in children aged 6 to 12 and one controlled trial in adults.

Vyvanse should not be taken by patients who have advanced arteriosclerosis; symptomatic cardiovascular disease; moderate to severe hypertension; hyperthyroidism; known hypersensitivity or idiosyncrasy to sympathomimetic amines; agitated states; glaucoma; a history of drug abuse; or during or within 14 days after treatment with monoamine oxidase inhibitors (MAOIs).

Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses in ADHD. Physicians should take a careful patient history, including family history, and physical exam, to assess the presence of cardiac disease. Patients who report symptoms of cardiac disease such as exertional chest pain and unexplained syncope should be promptly evaluated. Use with caution in patients whose underlying medical condition might be affected by increases in blood pressure or heart rate.

New psychosis, mania, aggression, growth suppression, and visual disturbances have been associated with the use of stimulants. Use with caution in patients with a history of psychosis, seizures or EEG abnormalities, bipolar disorder, or depression. Growth should be monitored in children during treatment with stimulants, and patients who are not growing (gaining height or weight) as expected may need to have their treatment interrupted.

Amphetamines have a high potential for abuse. Administration of amphetamines for prolonged periods of time may lead to drug dependence. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic uses or distribution to others and the drugs should be prescribed or dispensed sparingly. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events.

The most common adverse events reported in clinical studies of Vyvanse were: pediatric - decreased appetite, insomnia, abdominal pain, and irritability; adult - decreased appetite, insomnia, and dry mouth.

About Guanfacine Extended Release

Guanfacine Extended Release (GXR) is currently being studied as a once-daily, extended release formulation of guanfacine designed to provide steady delivery of drug throughout the day. GXR is pending FDA approval for the treatment of ADHD in children and adolescents. In clinical trials, GXR demonstrated significant reduction in ADHD symptoms. GXR is not a controlled substance and has no known mechanism for abuse or dependence.

Guanfacine, the active ingredient in GXR, is thought to work directly by binding selectively to alpha-2A adrenergic receptors located in the prefrontal cortex. The prefrontal cortex is an area of the brain associated with working memory, behavioral inhibition, regulation of attention, distractibility, and impulsivity. Although the mechanism of action of guanfacine in the treatment of ADHD is not fully understood, preclinical research suggests this selective alpha-2A agonist strengthens working memory and prefrontal cortex neuronal firing. This research supports the use of guanfacine for the treatment of ADHD.

In pivotal clinical trials, safety data showed that adverse events reported by participants using GXR were generally mild to moderate in severity, with the most common side effects being sedative in nature. Sedation-related, treatment-emergent adverse events were among the most common and were usually transient and mild or moderate in severity. Treatment-related adverse events greater than 10 percent included somnolence (32 percent), headache (26 percent), fatigue (18 percent), upper abdominal pain (14 percent) and sedation (13 percent). Syncope occurred in approximately 1 percent of pediatric patients in the clinical program. The majority of these cases occurred in the long-term, open label studies. Small to modest changes in blood pressure, pulse rate, and ECG parameters were observed.

Source:
Mindy Huber

Porter Novelli

View drug information on Vyvanse.

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