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:7/28/2017)... ... 28, 2017 , ... The Military Family Initiative (MFI), a ... the grant recipients of its inaugural community outreach grant program. , MOAA ... Falcon’s Landing Chapter, Sterling, Va.: $5,000. Community Veterans Collaboration. , ...
(Date:7/28/2017)... ... July 28, 2017 , ... Stephen Weber, MD, is excited to ... science of Platelet Rich Plasma (PRP). Founder of Weber Facial Plastic Surgery, Dr. Weber’s ... women. Through his groundbreaking PRP procedures, Dr. Weber is quickly bringing hair loss treatment ...
(Date:7/28/2017)... , ... July 28, 2017 , ... ActivePDF, a global ... Best Places to Work in Orange County. As a multi-year recipient, ActivePDF continues to ... County, CA. , ActivePDF is known for their code-driven suite of PDF automation products, ...
(Date:7/28/2017)... ... July 28, 2017 , ... At its first ginger symposium on July 18, ... ginger industry. The funds will be used for land preparation, seed and organic farming ... budget will support both new and existing small-hold farmers and will also help strengthen ...
(Date:7/28/2017)... ... July 28, 2017 , ... Date aired: July 17th, 2017 , Guest: ... of first generation immigrants before her, Rose Hong came to America to realize a ... the part of loving parents who made sure their daughter got to the U.S. ...
Breaking Medicine News(10 mins):
(Date:7/20/2017)... Minn. , July 20, 2017  Prime Therapeutics LLC ... Jonathan Gavras , M.D., following today,s Institute for Clinical and ... report on the effectiveness and value of abuse-deterrent formulations ... on the policy roundtable at the meeting. ... not a material cost benefit to the use of abuse-deterrent ...
(Date:7/17/2017)... -- MedX Holdings, Inc., the manufacturer and global distributor of ... today announced the national roll out of its MedX ... standard for the treatment of low back injuries and ... How it works: MedX ... who prescribe the MedX Home Back Machine Program for ...
(Date:7/14/2017)... DUBLIN , July 14, 2017 Endo International plc ... results on Tuesday, August 8, 2017.  Members of its senior management ... financial markets open at 8:30 a.m. ET. The ... (866) 497-0462, International (678) 509-7598, and the passcode is 45397076. ... A replay of the ...
Breaking Medicine Technology: