LEXINGTON, Massachusetts, May 16, 2017 /PRNewswire/ --
Shire plc (LSE: SHP, NASDAQ:
"The data being presented this year at APA by Shire help us to better understand the needs of adults with ADHD, a disorder that can impair adults in home, social and work settings," said Norman Atkins, Medical Lead for ADHD at Shire. "Based on our research, we understand that symptom burden can persist in adults with ADHD, including those who have been working with their healthcare professional to manage the disorder. We want to advance the understanding of the complex needs of adults with ADHD and how we can best address those."
Results from the studies will provide important insights on symptom burden and the continued unmet need to more effectively identify ADHD and treat the condition in adults. Research will also be presented on SHP465 (mixed salts of a single-entity amphetamine product), an investigational agent currently under review with the U.S. Food and Drug Administration (FDA) as a potential treatment for ADHD. In addition, research will be presented on Vyvanse® (lisdexamfetamine dimesylate), an approved treatment option for patients six years old and above with ADHD. Vyvanse is not for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity.
Specific presentations include:
*Further evaluation on the relationship between ADHD treatment and executive function is necessary. Vyvanse is not approved for the treatment of executive functions in patients with ADHD.
The poster presentations are intended for scientific discussion only.
IMPORTANT SAFETY INFORMATION
Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Vyvanse in a safe place to prevent misuse and abuse. Selling or giving away Vyvanse may harm others and is against the law.
Vyvanse is a stimulant medicine. Tell the doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Who should not take Vyvanse?
Do not take Vyvanse if you or your child is:
• taking or has taken an anti-depression medicine called a monoamine oxidase inhibitor (MAOI) within the past 14 days.
• sensitive or allergic to, or had a reaction to other stimulant medicines.
Problems that can occur while taking Vyvanse. Tell the doctor:
• if you or your child have heart problems or heart defects, high blood pressure, or a family
history of these problems. This is important because sudden death has occurred in people with heart problems or defects taking stimulant medicines, and sudden death, stroke and heart attack have happened in adults taking stimulant medicines. Since increases in blood pressure and heart rate may occur, the doctor should regularly check these during treatment. Call the doctor right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Vyvanse.
• if you or your child have mental problems, or a family history of suicide, bipolar illness, or depression. This is important because new or worsening behavior and thought problems or bipolar illness may occur. New symptoms such as seeing or hearing things that are not real, believing things that are not true, being suspicious, or having new manic symptoms may occur. Call the doctor right away if there are any new or worsening mental symptoms during treatment.
• if you or your child have circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud's phenomenon). Fingers or toes may feel numb, cool, painful, sensitive to temperature and/or change color from pale, to blue, to red. Call the doctor right away if any signs of unexplained wounds appear on fingers or toes while taking Vyvanse.
• if your child is having slowing of growth (height and weight); Vyvanse may cause this serious side effect. Your child should have his or her height and weight checked often while taking Vyvanse. The doctor may stop treatment if a problem is found during these check-ups.
• if you or your child are pregnant or plan to become pregnant. It is not known if Vyvanse may harm your unborn baby.
• if you or your child are breastfeeding or plan to breastfeed. Do not breastfeed while taking Vyvanse. Talk to your doctor about the best way to feed your baby if you take Vyvanse.
What are possible side effects of Vyvanse? The most common side effects of Vyvanse reported in ADHD studies include: • anxiety • dry mouth • trouble sleeping • decreased appetite • irritability • upper stomach pain • diarrhea • loss of appetite • vomiting • dizziness • nausea • weight loss
For additional safety information, click here for Prescribing Information and Medication Guide and discuss with your doctor.
NOTES TO EDITORS
Attention-Deficit/Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development and is inconsistent with developmental level.
Approximately 10.5 million adults and 6.4 million children in the U.S. are estimated to be living with ADHD. Approximately 50 to 66 percent of children with ADHD in childhood may continue to have ADHD symptoms as adults.
The specific etiology of ADHD is unknown. The diagnosis is made utilizing criteria specified in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5®). Only a trained healthcare professional can evaluate and diagnose ADHD.
Although there is no cure for ADHD, there are accepted treatments that have been demonstrated to improve symptoms. Standard treatments include educational approaches, psychological therapies which may include behavioral modification and/or medication. Ongoing assessment and treatment may be necessary.
DSM-5® is a registered trademark of the American Psychiatric Association.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.
Vyvanse® is a trademark of Shire LLC.
Vyvanse is available in capsule form (10, 20, 30, 40, 50, 60, and 70 mg) as well as a chewable tablet (10, 20, 30, 40, 50, and 60 mg).
Statements included herein that are not historical facts, including without limitation statements concerning future strategy, plans, objectives, expectations and intentions, the anticipated timing of clinical trials and approvals for, and the commercial potential of, inline or pipeline products, 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 adversely affected. The risks and uncertainties include, but are not limited to, the following:
a further list and description of risks, uncertainties and other matters can be found in Shire's most recent Annual Report on Form 10-K and in Shire's subsequent Quarterly Reports on Form 10-Q, in each case including those risks outlined in "ITEM 1A: Risk Factors", and in Shire's subsequent reports on Form 8-K and other Securities and Exchange Commission filings, all of which are available on Shire's website.
All forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Except to the extent otherwise required by applicable law, we do not undertake any obligation to update or revise forward-looking statements, whether as a result of new information, future events or otherwise.
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SOURCE Shire plc
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