Healthcare Industry News: Glaucoma
News Release - July 27, 2007
Shire's New ADHD Medication, VYVANSE(TM) (lisdexamfetamine dimesylate) Now Available in U.S. Pharmacies NationwideClinical study demonstrated efficacy until 6pm; May be of interest to mothers of children with ADHD
PHILADELPHIA, July 27 (HSMN NewsFeed) -- Shire plc (LSE: SHP ; NASDAQ: SHPGY ; TSX: SHQ ) announced today that VYVANSE (lisdexamfetamine dimesylate), a new once-daily medication approved to treat the symptoms of Attention Deficit Hyperactivity Disorder (ADHD), is now available in U.S. pharmacies nationwide. In a clinical study, VYVANSE provided consistent ADHD symptom control throughout the day based upon parent reports in the morning (approximately 10am), afternoon (approximately 2pm), and early evening (approximately 6pm). This may be of interest to mothers of children with ADHD based on a recent survey of 121 mothers of ADHD children aged 6 to 12 years, in which 60 percent of mothers reported that their child's ADHD medication stopped working before 6pm and 40 percent reported that their child's ADHD medication stopped working before 4pm.
"VYVANSE was shown in clinical studies to provide physicians with a treatment option for ADHD that offers consistent and effective control of ADHD symptoms throughout the day for up to 12 hours, from morning through homework and family time," said Frank A. Lopez, M.D., of the Children's Developmental Center in Winter Park, Fla. "Consistent symptom control throughout the day is important because kids have homework and after-school activities that require the same concentration and focus needed during the school day."
This new ADHD medication, VYVANSE, works with the patient's natural metabolism to deliver active medication and significantly improves core ADHD symptoms of inattention (e.g. focus, listening to, and following instructions) and behavior (hyperactivity and impulsivity).
"I know that my son, Kevin, has unique talents and abilities. When his ADHD symptoms were consistently controlled throughout the day, others could see the wonderful, talented boy that I see," said Rachel May, mother of Kevin Dixon, Jr. "After my son started taking VYVANSE in a clinical trial, I saw a difference in Kevin within the first week; others saw it, too."
The U.S. Food and Drug Administration (FDA) approved VYVANSE on February 23, 2007. VYVANSE is now available in retail pharmacies in 30 mg, 50 mg and 70 mg dosage strengths.
In the phase III, randomized, double-blind placebo-controlled study, all three doses of VYVANSE demonstrated significant improvements in ADHD Rating Scale (ADHD-RS-IV) scores compared with placebo (P <.0001) after four weeks of once-daily treatment. ADHD-RS-IV is a standardized, validated test for assessing symptoms of ADHD in children and for assessing their response to treatment. The effects were maintained throughout the day based on parent ratings reported at approximately 10 am, 2 pm, and 6 pm using the Connors' Parent Rating Scale (CPRS). The CPRS rates a child's behavior at home and in other environments where the parent has the opportunity to observe the child. The most common side effects reported in this study were decreased appetite, difficulty falling asleep, stomachache, and irritability.
Additional information about VYVANSE, Full Prescribing Information, and Medication Guide are available at www.vyvanse.com.
Approximately 7.8 percent of all school-age 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 U.S. Centers for Disease Control and Prevention (CDC). ADHD is one of the most common psychiatric disorders in children and adolescents. 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.
Important Safety Information
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 your child develops symptoms that suggest heart problems, such as chest pain or fainting. VYVANSE should not be taken if 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 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 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 decreased appetite, difficulty falling asleep, stomachache, and irritability.
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 your child has blurred vision while taking VYVANSE.
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 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 believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.
Shire's focused strategy is to develop and market products for specialty physicians. 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.
For further information on Shire, please visit the Company's website: 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, manufacturing and commercialization; the impact of competitive products, including, but not limited to the impact of those on Shire's Attention Deficit and Hyperactivity Disorder ("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; Shire's ability to benefit from its acquisition of New River Pharmaceuticals Inc.; the successful development of JUVISTAŽ (human TGF Beta 3) and other risks and uncertainties detailed from time to time in Shire plc's filings with the Securities and Exchange Commission, particularly Shire plc's Annual Report on Form 10-K for the year ended December 31, 2006.
Source: Shire plc
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