ATLANTA, July 22 /PRNewswire-FirstCall/ — Shire Limited , the global specialty biopharmaceutical company, today announced that it has launched VYVANSE(TM) (lisdexamfetamine dimesylate) for the treatment of adults with Attention Deficit Hyperactivity Disorder (ADHD). This launch follows the recent FDA approval of VYVANSE to treat ADHD in the adult population. VYVANSE is now available in U.S. pharmacies nationwide in six once-daily dosage strengths. To raise awareness of ADHD in adults and recognize the launch of VYVANSE for adults, Shire has partnered with celebrity designer Ty Pennington to shine the spotlight on living as an adult with ADHD. Pennington takes VYVANSE as part of his treatment plan to manage his ADHD symptoms so he can focus and get work done.
Pennington returns today to his hometown of Atlanta, where he will visit the Savannah College of Art and Design-Atlanta (SCAD-Atlanta) and announce the Daily Successes with ADHD Scholarship for an adult with ADHD who is pursuing an education or career in a creative field at SCAD-Atlanta. The $10,000 scholarship, sponsored by Shire, the maker of VYVANSE, will benefit an adult with ADHD who is enrolled in, or applying to, a graduate program at the art institution. The objective of the scholarship is to recognize achievements, and to motivate a student to continue to focus and achieve daily successes.
“As an adult with ADHD, I know, firsthand, the importance of understanding and treating ADHD. I believe if I’d been diagnosed and treated earlier, I would have struggled less as a child,” said Ty Pennington, host of ABC’s Extreme Makeover: Home Edition(TM). “Today, I have a very demanding schedule with long production days and constant travel, and I take VYVANSE to help control my ADHD symptoms so that I can focus and organize.”
ADHD Can Affect Adults’ Daily Lives
In adults with ADHD, symptoms can impact their professional life, social life, relationships and personal finances. In a new survey conducted by Shire of adults who experienced ADHD symptoms in a typical week, 88 percent of 328 adults surveyed reported that they have difficulty organizing tasks and activities, while 89 percent of 381 of these adults had difficulty finishing things, such as projects or work at home. These adults reported that this has had a negative impact on their daily life and activities. Additionally, among the 347 adults surveyed who are currently employed, 66 percent felt that they would do a better job at work if they were more focused and organized.
“Although ADHD can affect children and adults, the core symptoms of the disorder, inattention, hyperactivity, and impulsivity, may present differently in these two patient groups. For example, hyperactivity may present in adults as inner restlessness and inattention may present as a lack of focus and organization, poor time management, and an inability to finish tasks,” said David W. Goodman, M.D., director of the Adult Attention Deficit Disorder Center of Maryland and assistant professor of psychiatry and behavioral sciences at Johns Hopkins University School of Medicine. VYVANSE is one of several treatment options that may provide effective treatment control for adults with ADHD. In a clinical study, VYVANSE was shown to significantly improve ADHD symptoms within the first week: inattention — such as the ability to focus and organize — and hyperactivity and impulsivity — such as restlessness, and interrupting.”
Shire received approval in April 2008 from the FDA for VYVANSE for the treatment of ADHD in adults aged 18 to 55 years. VYVANSE was introduced in July 2007 for the treatment of ADHD in children aged 6 to 12 years. VYVANSE is available in six dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg. In its first year of availability, more than 2 million VYVANSE prescriptions have been filled.
VYVANSE works with the body’s natural metabolism to deliver active medication. VYVANSE is a once-a-day capsule that should be taken in the morning with or without food as prescribed by your doctor.
Additional information about VYVANSE and Full Prescribing Information are available at https://www.vyvanse.com/.
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.
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 U.S. 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 U.S. 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 U.S. population, approximately 9.8 million adults are believed to have ADHD. ADHD is a neurobiological 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, a child needs to demonstrate at least six of nine symptoms of inattention; and/or at least six of nine symptoms of hyperactivity/impulsivity; the onset of which appears before age 7 years; that some impairment from the symptoms is present in two or more settings (e.g., at school and home); that the symptoms continue for at least six months; and that there is clinically significant impairment in social, academic, or occupational functioning and the 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. The most common standard treatments include educational approaches, psychological, or behavioral modification, and medication.
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 and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire’s in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe. Shire believes that a carefully selected 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: https://www.shire.com/
“SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
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 including, but not limited to the successful development of and velaglucerase alfa (GA-GCB); manufacturing and JUVISTA(R) (Human TGF b3) commercialization including, but not limited to, the establishment in the market of VYVANSE(TM) (lisdexamfetamine dimesylate) (Attention Deficit and Hyperactivity Disorder (“ADHD”)); the impact of competitive products, including, but not limited to, the impact of those on Shire’s 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 INTUNIV(TM) (guanfacine extended release) (ADHD); Shire’s ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire plc’s filings with the Securities and Exchange Commission, including Shire plc’s Annual Report on Form 10-K for the year ended December 31, 2007.
Read more at https://www.redorbit.com/news/health/1489259/celebrity_designer_and_adhd_spokesperson_ty_pennington_partners_with_shire/#vpA57Xd1Kh6pTLKz.99