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:12/5/2016)... ... 06, 2016 , ... For many years, Andrew G. Zubinas has ... The beauty of the Lithuanian language and its poetry inspired him in ... Zubinas lyrically explores all aspects of a living, breathing forest where nothing ever stays ...
(Date:12/5/2016)... ... December 05, 2016 , ... “Epilepsy ... through tomorrow, December 6th, sparks a conversation about epilepsy, bearing down on the ... 26 people will be diagnosed with epilepsy within their lifetime. With such a ...
(Date:12/5/2016)... Reading, PA (PRWEB) , ... December 05, 2016 , ... ... partner in the United States and Canada for distribution of their natural fruits ... Hansen colors line is an exciting addition to our Life Sciences product portfolio,” ...
(Date:12/5/2016)... ... December 05, 2016 , ... ... Partners ("GPP") portfolio company, today announced it has acquired the assets of ... was previously a subsidiary of Chiltern International and focuses on clinical trial ...
(Date:12/5/2016)... (PRWEB) , ... December 05, 2016 , ... The new ... the individual looking to buy neoprene knee sleeves for lifting and any ... design focuses heavily on two main aspects to provide a higher quality knee sleeve ...
Breaking Medicine News(10 mins):
(Date:12/5/2016)... Eisai Inc. announced today new analyses and ... of the American Epilepsy Society (AES). ... adjunctive therapy for the treatment of partial onset seizures ... generalized tonic-clonic seizures (PGTC) in patients with epilepsy who ... Important Safety Information for FYCOMPA, including Boxed WARNING for ...
(Date:12/5/2016)... , Dec 5, 2016 Research and ... and Pregnancy Rapid Test Market Size, Share, Development, Growth and Demand ... ... The global female fertility and pregnancy rapid test market is ... global Female fertility and pregnancy rapid test market is witnessing high ...
(Date:12/5/2016)... AVIV, Israel , December 5, 2016 ... to identifying, in-licensing and developing promising therapeutic candidates, presents positive ... for BL-8040, the Company,s leading oncology platform at the ongoing ... in San Diego, California . ... , , ...
Breaking Medicine Technology: