GlaxoSmithKline and Shire Enter Agreement to Co-Promote Vyvanse(R) (lisdexamfetamine dimesylate) CII for Adult Attention Deficit Hyperactivity Disorder
"GSK has been active in discovering and developing medicines to treat psychiatric disorders for decades, and neuroscience is one of the company's key therapeutic categories," said
sales representatives are well positioned to provide physicians with information on the treatment of adult ADHD with Vyvanse and we look forward to helping meet the needs of adult patients with ADHD."
"Shire believes GSK is our ideal partner to promote Vyvanse because of its strength and leadership in CNS treatments," said
The GSK sales force is expected to begin promoting Vyvanse to physicians in
Vyvanse is a prodrug of dextroamphetamine, a stimulant, which is therapeutically inactive until metabolized in the body. Vyvanse is currently available in six dosage strengths of 20 mg, 30 mg,
40 mg, 50 mg, 60 mg, and 70 mg. Vyvanse was approved for marketing by FDA for ADHD in children aged 6 to 12 years in 2007; the adult indication was added in
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.
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 you or your child develops symptoms that suggest heart problems, such as chest pain or fainting.
Vyvanse should not be taken if you or 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 you or 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 you or 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.
Talk to your health care provider if your child experiences slowing of growth (height and weight). Children should have their height and weight checked periodically while taking Vyvanse. Your healthcare provider may stop Vyvanse treatment if a problem is found during these check-ups.
Vyvanse was generally well tolerated in clinical studies. The most common side effects reported in studies of Vyvanse were: children - decreased appetite, difficulty falling asleep, stomachache, and irritability; adult - decreased appetite, difficulty falling asleep, and dry mouth.
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 you or your child has blurred vision while taking Vyvanse.
ADHD is one of the most common psychiatric disorders in children and adolescents. Approximately 7.8 percent of all school-aged children, or about 4.4 million US children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the Centers for Disease Control and Prevention (CDC). The disorder is also estimated to affect 4.4 percent of US adults aged 18-44 based on results from the National Comorbidity Survey Replication, a nationally representative household survey, which used a lay-administered diagnostic interview to access a wide range of DSM-IV disorders. When this percentage is extrapolated to the full US population, approximately 9.8 million adults are believed to have ADHD. ADHD is a psychiatric behavioral 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, the person needs to demonstrate at least six of nine symptoms of inattention; and/or at least six of nine symptoms of hyperactivity/impulsivity; these symptoms continue for at least six months; some hyperactive-impulsive or inattentive symptoms that cause impairment were present before age 7 years; that some impairment from the symptoms is present in two or more settings (eg, at work, school, and home); and that there is clear evidence of clinically significant impairment in social, academic, or occupational functioning and 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. Standard treatments include educational approaches, psychological, or behavioral modification, and medication.
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For more information please visit: www.gsk.com
Shire PLC - 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 hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced 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 website: www.shire.com
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2008.
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SOURCE GlaxoSmithKline plc
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