Navigation Links
Investigational Data Presented for INTUNIV™ (guanfacine) Extended-Release Tablets When Coadministered With Stimulants Showed ADHD Symptom Improvement in Overall, Morning and Evening Assessments
Date:10/28/2010

NEW YORK, Oct. 28 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today presented research results of once-daily INTUNIV™ (guanfacine) Extended-Release Tablets, coadministered with stimulants in children and adolescents diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) who had suboptimal response to treatment with a long-acting stimulant alone.  At study end point, patients receiving INTUNIV coadministered with a stimulant had significantly reduced symptoms on the ADHD Rating Scale IV (ADHD-RS-IV) compared with those receiving placebo with a stimulant, regardless of morning or evening dosing.  These data were presented in a poster session at a major national scientific meeting of psychiatry in New York, NY.

"This study looked at patients who were taking a stable dose of a long-acting stimulant medicine but who continued to experience ADHD symptoms," said Timothy Wilens, MD, Staff in the Pediatric Psychopharmacology Unit at Massachusetts General Hospital and Associate Professor of Psychiatry at Harvard Medical School, who led the study.  "These findings provide greater insight into the use of INTUNIV when combined with a stimulant."

INTUNIV is a selective alpha-2A agonist approved for the treatment of ADHD in children and adolescents ages 6 to 17.  Efficacy was based on two pivotal studies (8 and 9 weeks in duration) of INTUNIV administered as monotherapy.  INTUNIV is indicated as an integral part of a total treatment program that may include counseling or other measures.

These data presented today were included as part of a supplemental New Drug Application (sNDA) submitted to the Food and Drug Administration (FDA) on April 28, 2010, seeking approval for INTUNIV as an ADHD
'/>"/>

SOURCE Shire plc
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related biology technology :

1. 52-Week Phase 3 Study Found Investigational Drug Dapagliflozin Plus Metformin Similar to Glipizide Plus Metformin in Improving Glycosylated Hemoglobin (HbA1c) in Adults with Type 2 Diabetes Mellitus
2. Repligen Files Investigational New Drug Application with FDA for First Drug Targeting the Core Genetic Defect of Friedreichs Ataxia
3. Aeterna Zentaris: FDA Approves Investigational New Drug (IND) Application for Doxorubicin Targeted Conjugate Compound, AEZS-108, in Bladder Cancer
4. Anavex comments on failure of Pfizer and Medivations Alzheimers investigational drug Dimebon during Phase 3 clinical trials
5. Peoria Clinical Research Center Tests Investigational Drug to Treat Painful Menstrual Cramps
6. Arena Pharmaceuticals Announces Merck Discontinues Development of Investigational Niacin Receptor Agonist Program for Atherosclerosis
7. Investigational Urine NGAL Biomarker Shows Promise to Monitor Cyclosporine Toxicity in Cardiac Transplant Patients
8. New Phase 3 Data Continue to Indicate that Wyeths Investigational 13-valent Vaccine Has the Potential to Broaden Coverage Against Pneumococcal Disease
9. FDA Accepts Investigational New Drug (IND) Application for Tigris Pharmaceuticals GGTI-2418
10. Medarex Announces Allowance of Investigational New Drug Application for Companys First Antibody-Drug Conjugate, MDX-1203
11. International Robotic Urology Symposium Reports on Benefits of Cooling During Robotic-Assisted Prostate Surgery and Introduces InnerCools New Investigational UroCool System
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/31/2014)... 2014 Having access to safe drinking ... battle in many corners of the globe. It’s a ... in northwestern Bolivia where many have been sickened by ... Fairfield University’s School of Engineering has been working to ... (UAC), “the united college for the peasants.” A branch ...
(Date:10/31/2014)... IL (PRWEB) October 30, 2014 ... Insight Product Development’s decades-long heritage in successful medical ... world context for what it takes to successfully ... space. As part of a two-hour on-site class, ... Kellogg school of business, McCormick School of Engineering, ...
(Date:10/31/2014)... (PRWEB) October 31, 2014 Jeffrey T. ... of Historical Studies within the College of Arts and ... to record the history of alcohol-based fuels in Illinois. ... many others have been working to build Illinois’ biofuels ... but overlooked aspect of the state's agricultural and business ...
(Date:10/31/2014)... This is a professional and in-depth ... The report provides basic biocides information, including its ... well as industry overview. This research covers the ... well as Global industry analysis covering macroeconomic environment ... Chinese biocides industry covers information on ...
Breaking Biology Technology:Fairfield University School of Engineering project reduces illness in rural community 2Fairfield University School of Engineering project reduces illness in rural community 3Insight Product Development Gives Northwestern University Students Foundation for Innovation Success 2Insight Product Development Gives Northwestern University Students Foundation for Innovation Success 3SIUE History Prof Manuel Working on Biofuels Book with NCERC 2SIUE History Prof Manuel Working on Biofuels Book with NCERC 3Biocides Market for International & Chinese Regional Development Analysis Now Available at DeepResearchReports.com 2Biocides Market for International & Chinese Regional Development Analysis Now Available at DeepResearchReports.com 3
... Scientists have developed a new form of stretchable ... such as spheres, body parts and aircraft wings, and ... of extreme mechanical deformations, without a reduction in electrical ... in such applications because it is intrinsically brittle and ...
... Ill. Finding a simple and convenient technique ... has been an elusive goal. With current analytical ... too poor, sample preparation too complex or sample ... Now, researchers at the University of Illinois have ...
... FRANKLIN LAKES, N.J., March 27 BD (Becton,Dickinson ... global medical technology,company, and Direct Relief International, a ... joint volunteer,initiative to strengthen healthcare in Ghana. A ... to Ghana for three weeks and work side-by-side,with ...
Cached Biology Technology:Foldable and stretchable, silicon circuits conform to many shapes 2Foldable and stretchable, silicon circuits conform to many shapes 3Femtogram-level chemical measurements now possible, U. of I. team reports 2BD and Direct Relief International Launch Second Volunteer Service Trip to Improve Healthcare in Ghana 2BD and Direct Relief International Launch Second Volunteer Service Trip to Improve Healthcare in Ghana 3
(Date:10/30/2014)... 30, 2014 – Bacteria in the gastrointestinal tract ... digestion. Yet, these same bacteria can induce strong ... penetrate the gut and enter the bloodstream. , ... protect the body, chronic or systemic inflammation is ... has established the involvement of inflammatory processes in ...
(Date:10/29/2014)... lose their hair as a consequence of chemotherapy will ... the scalp cooling technology that prevents hair loss. , ... pioneered by global scalp cooling manufacturing company, Paxman Coolers, ... department of the University of Huddersfield. , The research ... has a background in the pharmacology of cancer treatment, ...
(Date:10/29/2014)... make their food, but they also need protection from its ... group of molecules in plants that shields them from sun ... the American Chemical Society , one team reports on the ... Zwier and colleagues at Purdue University note that the harsh ... damage to plant DNA and, as a result, hinder plant ...
Breaking Biology News(10 mins):Breakdown in gut barriers to bacteria may promote inflammation and craving in alcoholics 2New technology on the way to aid cancer suffers who lose their hair after chemotherapy 2
... suggests that the prolonged fatigue after mild exercise that ... is distinct from the inherent muscle weakness caused by ... in Nature Advance Online Publication Oct. 26, ... exercise-induced fatigue in mouse models of muscular dystrophy. Moreover, ...
... use flower scent to guide their nest-mates to good ... of London. For any animal, finding food on ... animals such as bees reduce these problems by informing ... the search. Honeybees use their waggle-dance to tell ...
... for the Rockot launcher that shall carry ESA,s GOCE ... of a failure in the guidance and navigation system ... anomaly was discovered during the spacecraft,s launch preparation tests ... to the postponement of the launch. , The cause ...
Cached Biology News:Study may explain exercise-induced fatigue in muscular dystrophies 2Study may explain exercise-induced fatigue in muscular dystrophies 3
RAT ANTI MOUSE F4/80 ANTIGEN:BIOTIN Immunogen: Thioglycollate stimulated peritoneal macrophages from C57/BL mice...
SHEEP ANTI FLECAINIDE...
ANTI PIG LDH H4...
RAT ANTI MOUSE F4/80 ANTIGEN:BIOTIN Immunogen: Thioglycollate stimulated peritoneal macrophages from C57/BL mice...
Biology Products: