Navigation Links
Results of the Phase III Pivotal Study of VYVANSE(TM) (Lisdexamfetamine Dimesylate) for the Treatment of ADHD in Adults Presented at National Scientific Meeting of Psychiatrists
Date:5/8/2008

VYVANSE demonstrated significant improvement in ADHD symptoms in adults

WASHINGTON, May 8 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today presented the results of a phase III pivotal study in which VYVANSE demonstrated significant improvements in Attention Deficit Hyperactivity Disorder (ADHD) symptoms in adults and met all safety and efficacy endpoints.

"Adults with ADHD often find it challenging to focus and organize during the day. The disorder may impact many aspects of their lives from career to family and personal commitments," said Lenard A. Adler, M.D., lead researcher in this study and director of the Adult ADHD program at the NYU Langone Medical Center, associate professor of psychiatry, neurology and child and adolescent psychiatry at the New York University School of Medicine, as well as author of Scattered Minds: Help and Hope for Adults with ADHD (G. P. Putnam's Sons 2006). "This study demonstrated that VYVANSE significantly improved ADHD symptoms in adults, including inattention, such as the ability to focus, organize and complete tasks, which are essential during an adult day, as well as hyperactivity, such as restlessness, and impulsivity."

This double-blind, placebo-controlled, four-week, forced-dose study in 414 adults aged 18 to 55 years showed that treatment with VYVANSE at all doses studied (30 mg, 50 mg, 70 mg) provided a significant reduction in ADHD Rating Scale (ADHD-RS-IV) scores within one week that were observed throughout the full treatment period. At endpoint, VYVANSE demonstrated a significant improvement in ADHD symptoms, based on a 43 percent reduction in ADHD-RS scores. This is the largest placebo-controlled stimulant trial of ADHD in adults conducted to date.

Additional Study Findings

Investigators also measured the efficacy of VYVANSE with the Clinical Global Impressions-Improvement (CGI-I) scale and found that the percentage of subjects taking VYVANSE rated "much improved" or "very much improved" was approximately 60 percent across all doses and was significantly greater than placebo.

The most commonly reported adverse events in this study were generally mild to moderate in severity and included decreased appetite, insomnia and dry mouth.

On April 23, 2008, Shire received approval from the U.S. Food and Drug Administration (FDA) for VYVANSE for the treatment of ADHD in adults aged 18 to 55 years. The FDA approved VYVANSE for the treatment of ADHD in children aged 6 to 12 years on February 23, 2007.

Additional information about VYVANSE and Full Prescribing Information are available at http://www.vyvanse.com.

The study was supported by funding from Shire.

Note to Editors

ADHD-RS-IV is a standardized, validated test for assessing symptoms of ADHD and for assessing their response to treatment. The scale, which contains 18 items, is based on the ADHD diagnostic criteria as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision(R), a publication of the American Psychiatric Association.

The CGI-I scale is a standard assessment used to rate the severity of a patient's illness and improvement over time.

About ADHD

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 U.S. 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 assess a wide range of DSM-IV disorders. 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.

About VYVANSE

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.

SHIRE PLC

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: http://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 JUVISTA(R) (Human TGF(beta)3) and velaglucerase alfa (GA-GCB); manufacturing and 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.


'/>"/>
SOURCE Shire plc
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
2. Lexicon to Present Research Results at American Chemical Society Meeting Regarding Target of LX1031 Drug Candidate
3. Positive Kuvan(TM) Pivotal Phase 3 Trial Results Published in The Lancet
4. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
5. Tapestry Reports Second Quarter 2007 Results
6. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
7. Emisphere Technologies, Inc. Announces 2007 Second Quarter Financial Results
8. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
9. Genta Incorporated Announces Second Quarter 2007 Financial Results and Corporate Highlights
10. Vical Reports Second Quarter 2007 Financial Results, Allowance of Pandemic Influenza IND and Other Advances in Product Development Programs
11. MicroDose Announces Positive Results From the QDose Inhaled Insulin Glucose Clamp Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/30/2016)... Nov 30, 2016 Research and Markets has ... Monitoring Devices 2017 - MedCore" report to their offering. ... , , ... the skull. In healthy individuals, it is circulated though the brain and ... where the amount of CSF surrounding the brain changes significantly. ...
(Date:11/30/2016)... Research and Markets has announced the addition of the ... their offering. ... Detachable coil embolization is a minimally invasive method ... embolization treatment of cerebral aneurysms is less invasive and requires less recovery ... wall of an artery in the brain. This area bulges in the ...
(Date:11/30/2016)... Calif. , Nov. 30, 2016 Varian ... it was named America,s Most JUST Company in the ... and Forbes magazine,s inaugural "JUST 100 List." ... of the largest surveys ever conducted on attitudes towards ... months. This inaugural list ranks U.S companies against their ...
Breaking Medicine Technology:
(Date:12/2/2016)... (PRWEB) , ... December 02, 2016 , ... ... proudly announces the launch of its 60-day free trial program for all of ... shipping make the offer a truly hassle free experience. , FlexiSpot’s unique desktop ...
(Date:12/2/2016)... ... 02, 2016 , ... With the number of pain management programs available for ... find the one that works for them. When an inventor from Suisun City, Calif., ... and decided to share it with others. , He developed a prototype for PRO ...
(Date:12/2/2016)... ... December 02, 2016 , ... Mediaplanet is proud to ... which covers the innovative treatments, therapeutic technologies, and revolutionized nutrition that are helping ... prolonging life 6 years in the last 3 decades,” says Dr. Valentine Fuster, ...
(Date:12/2/2016)... ... , ... Sourced from the Isbre Springs beneath the 5,000 year old Hardanger ... of just 6 ppm TDS (Total Dissolved Solids) in addition to its excellent taste ... several ShopRite and FoodTown stores in NJ and received rave comments from consumers. , ...
(Date:12/2/2016)... Francisco, CA (PRWEB) , ... December 02, 2016 ... ... digitally-enabled care journeys, announced today that it has raised $6.0 million in an ... inspired by Clarify Health’s conviction that patients and their caregivers can receive far ...
Breaking Medicine News(10 mins):