Navigation Links
FDA Approves Labeling Change for VYVANSE(R) (lisdexamfetamine dimesylate) CII to Include Supplementary Clinical Data Supporting Efficacy at 13 Hours Postdose in Children Aged 6 to 12 with ADHD
Date:6/1/2009

our study for patients taking VYVANSE during the double-blind treatment period, which were greater than or equal to 2 percent, were insomnia, decreased appetite, and anorexia.

VYVANSE Demonstrated Significant Efficacy Versus Placebo at 13 Hours Postdose

The study that led to this approval of revised labeling for VYVANSE was a randomized, double-blind, placebo-controlled, analog classroom study that assessed the efficacy and safety of VYVANSE in 129 children aged 6 to 12 years with ADHD. Following a four-week, open-label, dose-optimization phase with VYVANSE at 30 mg, 50 mg, and 70 mg doses, patients entered a two-week, double-blind, crossover phase where they were randomized into two groups. One group received their optimal dose of VYVANSE the first week and placebo the second week. The second group received placebo the first week and their optimal dose of VYVANSE the second week.

The primary objective of this study was to assess the time of onset of VYVANSE compared with placebo, as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham Deportment (SKAMP-D) rating scale. Secondary objectives included assessment of the duration of efficacy of VYVANSE compared with placebo, as measured by the SKAMP-D scale, and assessment of efficacy and time of onset of VYVANSE compared with placebo as measured by SKAMP Attention (SKAMP-A), and Permanent Product Measure of Performance (PERMP) scales.

In the study, VYVANSE demonstrated significant efficacy versus placebo at 1.5 hours, the first time point measured. Further, VYVANSE treatment was associated with significant efficacy as measured by both subjective (SKAMP-D and SKAMP-A) and objective (PERMP) assessments from the first time point (1.5 hours) through the last time point (13 hours) assessed during the classroom day, and at all time points in between (2.5, 5.0, 7.5, 10.0 and 12.0 hours).

Safety was also evaluated during the stu
'/>"/>

SOURCE Shire plc
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related biology technology :

1. FDA Approves Boston Scientifics Next-Generation TAXUS(R) Liberte(R) Atom(TM) Stent System
2. Arpida Annual General Meeting of Shareholders Approves All Board Proposals
3. Health Canada Approves SIMPONI(TM) (golimumab) for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
4. FDA Approves Label Change for Non-Invasive Fibroid Treatment
5. FDA Approves SyntheMeds REPEL-CV(R) Adhesion Barrier for Use in Pediatric Cardiac Surgery
6. FDA Approves SYMBICORT(R) for Chronic Obstructive Pulmonary Disease (COPD)
7. FDA Approves Apidra(R) SoloSTAR(R) - a Prefilled Disposable Insulin Pen
8. European Commission Approves EFIENT(R) (prasugrel) for Patients with Acute Coronary Syndrome Undergoing PCI
9. Encouraging high-risk research: DFG approves funding for 2 new Reinhart Koselleck projects
10. FDA Approves ULORIC(R) (febuxostat) for the Chronic Management of Hyperuricemia in Patients with Gout
11. FDA Approves Clinical Studies of a Novel Anti-Cancer Drug Developed by Italian Researchers
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/26/2015)... ... August 26, 2015 , ... MediVet ... a second US laboratory is to open in Manhattan, Kansas in early October, ... and long-term growth of research and development through collaboration with researchers from Kansas ...
(Date:8/26/2015)... 2015  Platform therapeutic company Symic Biomedical, Inc. ... $1.5M Phase II SBIR grant from the National ... therapeutic agent to reduce arteriovenous fistula (AVF) failures, ... renal disease (ESRD) patients undergoing hemodialysis. The two-year ... and Digestive and Kidney Diseases (NIDDK), will allow ...
(Date:8/26/2015)... , August 26, 2015 ... factors fueling the optimism in biotech,s forecast is ... and life sciences advancements.  Active biotechnology & healthcare ... BioSciences, Inc. (OTCQB: PBIO), Sequenom, Inc. (NASDAQ: ... ), Raptor Pharmaceutical Corp. (NASDAQ: RPTP ) ...
(Date:8/25/2015)... ... August 25, 2015 , ... Vets Plus, Inc. recently installed ... company has added a AS16 Sharples centrifuge to harvest products after fermentation. The ... fungal fermentation process development. , The new centrifuge greatly expands production capabilities ...
Breaking Biology Technology:MediVet Biologics Animal Health Secures Additional Laboratory Facility in Manhattan, Kansas 2MediVet Biologics Animal Health Secures Additional Laboratory Facility in Manhattan, Kansas 3Symic Biomedical Awarded $1.5MM NIH Phase II SBIR Grant to Develop its Proteoglycan Mimetic Therapeutics to Reduce Vascular Access Failures in ESRD 2Symic Biomedical Awarded $1.5MM NIH Phase II SBIR Grant to Develop its Proteoglycan Mimetic Therapeutics to Reduce Vascular Access Failures in ESRD 3New Collaborations & Mergers For Research of Molecular Biomarkers in Human Diseases & Clinical Trials for Cancer Therapies Fueling Growth in Multi-Billion Dollar Life Sciences Market 2New Collaborations & Mergers For Research of Molecular Biomarkers in Human Diseases & Clinical Trials for Cancer Therapies Fueling Growth in Multi-Billion Dollar Life Sciences Market 3New Collaborations & Mergers For Research of Molecular Biomarkers in Human Diseases & Clinical Trials for Cancer Therapies Fueling Growth in Multi-Billion Dollar Life Sciences Market 4New Collaborations & Mergers For Research of Molecular Biomarkers in Human Diseases & Clinical Trials for Cancer Therapies Fueling Growth in Multi-Billion Dollar Life Sciences Market 5New Collaborations & Mergers For Research of Molecular Biomarkers in Human Diseases & Clinical Trials for Cancer Therapies Fueling Growth in Multi-Billion Dollar Life Sciences Market 6New Collaborations & Mergers For Research of Molecular Biomarkers in Human Diseases & Clinical Trials for Cancer Therapies Fueling Growth in Multi-Billion Dollar Life Sciences Market 7New centrifuge and fermentor expand product development capacity at Vets Plus 2
... Growing Generations, the nation,s,largest surrogacy agency, has launched ... to men with HIV and allows them to use,their ... program is made possible due to advances in technology ... the implementation of recent California,legislation enacted in January that ...
... 3 DermTech, a biotechnology,company developing molecular diagnostics ... today announced that Herbert A. Fritsche,Ph.D., has joined ... Chief of Clinical Chemistry at M.D. Anderson Cancer ... development and validation of cancer,diagnostics for early disease ...
... CORAL GABLES, Fla., June 3 Catalyst,Pharmaceutical ... biopharmaceutical company,that acquires, in-licenses, develops and commercializes ... and obsessive compulsive disorders,today announced the filing ... and Exchange Commission (SEC). After the shelf ...
Cached Biology Technology:Growing Generations Announces Surrogacy Program for Men with HIV 2DermTech Names Herbert A. Fritsche, Ph.D., Chief of Clinical Chemistry at M.D. Anderson Cancer Center to Company's Scientific Advisory Board 2Catalyst Pharmaceutical Partners, Inc. Files Form S-3 Shelf Registration Statement 2Catalyst Pharmaceutical Partners, Inc. Files Form S-3 Shelf Registration Statement 3
(Date:7/31/2015)... SHENZHEN, China , 31 de julho de 2015 ... Genômica (ICG-10, www.icg-10.org ) será realizada pela BGI de ... China . A conferência está ... inauguração em 2006, a ICG se tornou uma das ... e um dos encontros científicos mais dinâmicos, entusiastas e ...
(Date:7/31/2015)... China , 31 de julio de 2015 ... www.icg-10.org ) se celebrará por medio de BGI del 22 al ... . Este año, la conferencia celebra ... ICG se ha convertido en una de las reuniones anuales ... ser una de las reuniones más dinámicas, entusiastas y mejores ...
(Date:7/31/2015)... --NXT-ID, Inc. (NASDAQ: NXTD ) ("NXT-ID" or the ... mobile commerce market and creator of the Wocket® smart ... for ELECTRONIC CRYPTO-CURRENCY MANAGEMENT METHOD AND SYSTEM ... crypto-currencies such as Bitcoin into the consumer market of ... manage all payments.  The technology manages ...
Breaking Biology News(10 mins):A 10a. Conferência Internacional sobre Genômica (ICG-10) será em outubro 2A 10a. Conferência Internacional sobre Genômica (ICG-10) será em outubro 3La 10th International Conference on Genomics (ICG-10) se llevará a cabo en octubre 2La 10th International Conference on Genomics (ICG-10) se llevará a cabo en octubre 3NXT-ID Patents Electronic Crypto-Currency Management Technology 2NXT-ID Patents Electronic Crypto-Currency Management Technology 3NXT-ID Patents Electronic Crypto-Currency Management Technology 4
... generation of cancer chemotherapeutic drugs specifically targets mutant enzymes ... uncontrolled cell growth. As promising as these drugs are, ... the tendency to fight back. A major goal of ... desperation. , In a forthcoming issue of Cancer Cell, ...
... Scientists have identified the first biochemical marker linked to sleep ... in activity when sleep deprivation is prolonged. , Researchers hope ... that will aid diagnosis and treatment of sleep disorders and ... at the wheel of a car or in other dangerous ...
... of these epidermal neural crest stem cells in the ... showing that these cells are distinctly different from other ... valuable resource for future mouse neural crest stem cell ... Maya Sieber-Blum's laboratory, co-authored by Yao Fei Hu, Ph.D., ...
Cached Biology News:Distinguishing friend from foe in the battle against cancer 2Distinguishing friend from foe in the battle against cancer 3First biomarker for human sleepiness identified in fruit flies 2First biomarker for human sleepiness identified in fruit flies 3Stem cells found in adult hair follicles may provide alternative to embryonic stem cells 2
... directed toward examining a novel object in the ... instruments all built around a video camera, frame ... track two fields at once and up to ... positions and records them, but also allows video ...
... foraging behavior.The Spatial Behavior line is a family ... frame grabber, and feature extraction software and that ... to 6 moving animals. Software automatically extracts ... video replay of all or machine-selected events. ...
... 22K enables researchers to simultaneously characterize ... biological functions, growth processes, and biotic ... contains sequences representing estimated coverage of ... focuses on well annotated genes selected ...
... CHEMICONs ELF 97 Cytological Labeling Kit provides ... the detection of cellular targets, including cell-surface ... Cytological Labeling Kit contains the patented ELF ... fluorescent yellow-green precipitate at the site of ...
Biology Products: