Navigation Links
Phase III pivotal results presented of VYVANSE to treat ADHD in adults
Date:5/8/2008

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.


'/>"/>

Contact: Lucia Lodato
lucia.lodato@porternovelli.com
917-617-3058
Porter Novelli
Source:Eurekalert

Related medicine news :

1. Preliminary Results from Phase 2 Genzyme Study Highlight Potential of Novel Oral Compound for Gaucher Disease
2. NicOx Announces U.S. Phase 2a Results for PF-03187207 and Gives an Update on Continuing NO-prostaglandin Program
3. Phase 3 data Re: Anti-RSV antibody to be presented at Pediatric Academic Societies Annual Meeting
4. Wal-Mart Launches Phase Three of $4 Prescription Program
5. Sanofi-aventis: Encouraging First-Quarter 2008 Results Further Positive Phase III Results for Eplivanserin
6. Antipodean Pharmaceuticals Announces Results of Phase 2 Study of Lead Compound MitoQ(R)
7. Arpida Provides Comprhensive Overview of Pivotal Phase III Trial Data
8. QLT initiates phase II study of punctal plug drug delivery system for glaucoma & ocular hypertension
9. Cystic Fibrosis Foundation announces positive early results for phase 2 clinical trial of VX-770
10. Many Phase 3 Cancer Drug Trials Yield Effective Medicines
11. Cancer treatments in phase 3 trials successful up to half of the time
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... ... December 02, 2016 , ... Universal Medical Systems, ... and the first company to offer robotic imaging to veterinary medicine is sponsoring ... # 941 for the American Association of Equine Practitioners 62nd Annual Convention from ...
(Date:12/2/2016)... ... , ... Rijuven Corp launches rejiva ( http://www.rejiva.com ), a unique wearable technology ... health technology on the market can deliver all that rejiva can. , “Rejiva promotes ... their health than the usual heart rate and steps taken”, adds Evens Augustin, CEO ...
(Date:12/2/2016)... Viejo, California (PRWEB) , ... December 02, 2016 , ... ... will allow FCPX editors to create versatile lower third titles with just a few ... , Pro3rd Accents Volume 2 includes 30 lower third animations. Choose from various styles ...
(Date:12/2/2016)... ... 02, 2016 , ... On November 24th, 2016, Thanksgiving morning, ... different sites throughout Miami-Dade and Broward counties. This is the largest meal delivery ... Thanksgiving morning by putting together individual meals via assembly lines and passing them ...
(Date:12/2/2016)... ... December 02, 2016 , ... Date aired: November ... Type 2 Diabetes: The Owner’s Manual, http://realtimepressrelease.com/press-releases-tagged-with/daryl-wein , Sharon Kleyne, ... Water, Global Climate Change and Your Health radio program syndicated on Voice of ...
Breaking Medicine News(10 mins):
(Date:12/2/2016)... , December 2, 2016 ... Vitro Diagnostics/IVD Market by Product (Instruments, Reagents, Software), ... (Diabetes, Oncology, Cardiology, Nephrology, Infectious Diseases) - Forecast ... is valued at USD 60.22 Billion in 2016. ... CAGR of 5.5% during the forecast period (2016-2021) ...
(Date:12/2/2016)...  PipelineRx, a leading medication management technology company ... of its SaaS-based telepharmacy platform, PowerGridRx™ , ... Midyear Clinical Meeting and Exhibition, December 5-7 in ... 300 hospital clients nationally, the Company is a ... dramatically improve pharmacy operations, enhance patient safety, and ...
(Date:12/2/2016)... -- On Thursday, December 1st 2016, the ... development and innovation in the biopharmaceutical industry at its ... the presence of Sergey Tsyb, Vice Minister of Industry ... , Natalia Sanina, First Vice Chairman of the State ... Roszdravnadzor, National Service of Control in Healthcare, Sergey Muravev, ...
Breaking Medicine Technology: