Navigation Links
VYVANSE(TM) Drug for the Treatment of ADHD in Adults

PHILADELPHIA, Pennsylvania, Shire plc announced today that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for VYVANSE(TM) (lisdexamfetamine dimesylate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults. This application is subject to a 10-month FDA review period.

"ADHD is a treatable disorder that affects adults as well as children," said Matthew Emmens, Shire Chief Executive Officer. "We are pleased with the results of VYVANSE studies conducted in adults and we believe this product will meet an important need in the adult ADHD marketplace. VYVANSE is a priority in our ADHD portfolio and we are committed to developing this next generation ADHD medication so that adults diagnosed with ADHD may benefit from treatment with VYVANSE."

VYVANSE is a prodrug stimulant that is therapeutically inactive until metabolized in the body and active d-amphetamine is released. VYVANSE is different from other oral long acting stimulants of amphetamine and methylphenidate that rely on delivery systems which may be affected by pH and GI transit time.

Shire plans to announce full results from its phase III clinical trial for the treatment of ADHD in adults at a major scientific conference in Q4 2007.

The FDA approved VYVANSE on February 23, 2007, to treat symptoms of ADHD in children aged 6 to 12. Additional information about VYVANSE and Full Prescribing Information are available at www.vyvanse.com.

About ADHD

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. The disorder is also estimated to affect approximately 9.8 million adults across the U.S. ba sed on a retrospective survey of adults aged 18 to 34, projected to the full U.S. adult population.

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.


'"/>




Related medicine news :

1. Advances in Treatment of Cataracts
2. Recommendations for Treatment of Blood Pressue
3. Treatment for Menieres disease
4. Treatment for pre-menstrual syndrome is ineffective
5. Better Treatment for obesity
6. Gene Treatment for Heart Disease
7. More People Seeking Treatment for Depression
8. Focused Treatment For Childhood Cancer
9. Inadequate Drug Treatment For Youth
10. FDA Approves New surgery Treatment for Farsightedness
11. Treatment of antibiotics ineffectual in bronchitis
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:10/12/2017)... ... October 12, 2017 , ... HMP , a leader in healthcare ... Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were announced during ... , The annual award competition recognizes editorial and design excellence across a range of ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... On Saturday, ... a treadmill relay – Miles by Moonlight to raise money for the American Heart ... or more. , Teams will work together to keep their treadmills moving for ...
(Date:10/12/2017)... ... October 12, 2017 , ... Health Literacy Innovations ... literacy software tool, and the Cancer Patient Education Network (CPEN), an independent professional ... announce a new strategic alliance. , As CPEN’s strategic partner, HLI will ...
(Date:10/12/2017)... ... October 12, 2017 , ... Vohra ... care advancements to physician colleagues, skilled nursing facility medical directors and other clinicians ... Waters of Wound Care." , "At many of these conferences we get to ...
(Date:10/12/2017)... (PRWEB) , ... October 12, ... ... in life sciences content management, presents its enhanced Pepper Flow promotional review ... 16 -18, 2017. Pepper Flow’s increased insight-driven capabilities help marketers streamline the ...
Breaking Medicine News(10 mins):
(Date:9/25/2017)... , Sept. 25, 2017   Montrium ... Master File solutions, today—from the IQPC Trial Master ... , NL)—announced that EastHORN Clinical Services has ... clinical programs and TMF management. EastHORN, a leading ... eTMF platform to increase transparency to enable greater ...
(Date:9/23/2017)... Pa. , Sept. 22, 2017 Janssen ... a complete response letter from the U.S. Food and ... seeking approval of sirukumab for the treatment of moderately ... letter indicates additional clinical data are needed to further ... moderately to severely active RA. ...
(Date:9/22/2017)... , Sept. 22, 2017 AVACEN Medical (AVACEN) ... is now successfully helping those with the widespread pain ... Fibromyalgia diagnosed Amanda in Essex, England ... washing my hair, experiencing no sleep at all, tremendous ... spasm… I cannot recommend [the AVACEN 100] enough, how ...
Breaking Medicine Technology: