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

treatment combined with stimulants in this same patient population.  The application is currently under review.  The target FDA action date is February 28, 2011.

In This Investigational Study, Coadministration of INTUNIV With a Stimulant Showed Significant ADHD Symptom Improvement Over Stimulant Alone When Dosed Either in the Morning or Evening

This multicenter, double-blind, randomized, placebo-controlled study took place over 9 weeks in 455 patients aged 6 to 17 years with ADHD who had suboptimal response* to treatment with a stimulant.

Throughout this dose-optimized study, patients continued to take their prescribed dose of a stimulant, with the addition of a morning or evening dose of INTUNIV (1 mg, 2 mg, 3 mg, or 4 mg) or placebo.  The primary efficacy measure for the study was the ADHD-RS-IV.  ADHD-RS-IV is a standardized tool for evaluating symptoms of ADHD and assessing response to treatment, in which clinicians can rate patients within a scoring range of 0 to 54, depending on the severity of symptoms.  At end point, a significantly greater percentage of patients in the morning and evening administration of INTUNIV and stimulant groups compared with those taking placebo with a stimulant met criteria for symptomatic remission (ADHD-RS-IV less than or equal to 18).  Data from the primary efficacy analysis of the study were previously presented at a national meeting of psychiatry in May 2010.  

Secondary efficacy measures were based on scores from the Conners' Global Index – Parent (CGI-P) morning and evening assessment, and the exploratory Before-School Functioning Questionnaire (BSFQ).  On a weekly basis, parents completed 2 assessments of the CGI-P, each composed of 10 questions.  The first assessment evaluated patient behaviors in the morning before school, and during the week before the study visit.  The second assessment evaluated patient behaviors in the evening,
'/>"/>

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:8/28/2014)... Earlier this month, a report was created by ... Air Force on the performance of vehicles using an ... of fuel made from mustard seeds, offered great potential ... Eco friendly future. In fact, every branch of the ... of foreign oil over the next few years. They ...
(Date:8/28/2014)... (PRWEB) August 28, 2014 Supplementing ... offering a promotion for Eppendorf Safe Lock ... to purchase the highest quality tubes at an ... ideal for customers doing chemical, medical, pharmaceutical, and ... who are not regularly able to afford Eppendorf ...
(Date:8/27/2014)... Lake City, Utah (PRWEB) August 27, 2014 ... construction that will expand its current Salt Lake City ... currently underway outside of Utah to ultimately create 1,000 ... next 20 years. , “Utah is home to ... of whom can be credited with Varian’s success in ...
(Date:8/27/2014)... -- Rhythm, a biopharmaceutical company developing peptide therapeutics that ... metabolic disorders, announced today that it has filed a ... and Exchange Commission (SEC) relating to the proposed initial ... number of shares to be offered and the price ... Citigroup and Cowen and Company will act ...
Breaking Biology Technology:Can Small Farmers and a New Seed Based Biofuel “Green” the World? Major Universities and Even the U.S. Air Force Seem to Think So 2Can Small Farmers and a New Seed Based Biofuel “Green” the World? Major Universities and Even the U.S. Air Force Seem to Think So 3Can Small Farmers and a New Seed Based Biofuel “Green” the World? Major Universities and Even the U.S. Air Force Seem to Think So 4Can Small Farmers and a New Seed Based Biofuel “Green” the World? Major Universities and Even the U.S. Air Force Seem to Think So 5Eppendorf Safe Lock Centrifuge Tube Promotion Now Available at Major Pipette Distributor Pipette.com 2Eppendorf Safe Lock Centrifuge Tube Promotion Now Available at Major Pipette Distributor Pipette.com 3Varian Medical Systems Groundbreaking on Facility Expansion Triggers Influx of New Jobs to Salt Lake 2Varian Medical Systems Groundbreaking on Facility Expansion Triggers Influx of New Jobs to Salt Lake 3Rhythm Files Registration Statement for Proposed Initial Public Offering 2
... Ind., Jan. 23 Zimmer Holdings, Inc.,(NYSE: ZMH ... announced,today it will be participating in the Wachovia Securities ... 10:15 a.m. Eastern Time., A live webcast of ... at http://investor.zimmer.com . The webcast will,be archived for ...
... QED International Associates, Inc.,administrator for the HealthShares(TM) ... HealthShares(TM) Exchange-Traded Funds, today announced,that effective at the ... Pharmaceuticals Inc. (Nasdaq: REGN ) will replace ... HealthShares(TM) Composite Index. MGI Pharma is being,acquired by ...
... 23 /PRNewswire/ - Dalton Medicinal Chemistry Partners,the ... announces that it,has achieved another targeted milestone ... (Canada) Ltd., Dalton Medicinal Chemistry Partners ... and synthesize novel compounds against an,antiviral target ...
Cached Biology Technology:QED International Associates Announces Changes to the HealthShares(TM) Composite, HealthShares(TM) Cancer and HealthShares(TM) Neuroscience Indexes 2
(Date:8/27/2014)... Calif. , Aug. 27, 2014  WaferGen Bio-systems, ... its previously announced underwritten public offering of units of ... per unit for gross proceeds of $20 million, prior ... payable by the Company.  The shares and warrants are ... Each unit sold in the offering consists of ...
(Date:8/27/2014)... 2014. Using functional near infrared spectroscopy (fNIRS), Kessler ... between people with multiple sclerosis (MS) and healthy ... which brain activation was studied using fNIRS while ... and cognition using functional near infrared spectroscopy (fNIRS) ... 11 by Brain Imaging and Behavior . ...
(Date:8/27/2014)... fish began exploring land and evolved into tetrapods today,s ... fish used their fishy bodies and fins in a terrestrial ... mysteries. , Researchers at McGill University published in the ... Polypterus , to help show what might have happened ... Polypterus is an African fish that can breathe ...
Breaking Biology News(10 mins):WaferGen Bio-Systems Announces Successful Completion of Public Offering Raising $20 Million 2WaferGen Bio-Systems Announces Successful Completion of Public Offering Raising $20 Million 3Kessler Foundation researchers publish first study of brain activation in MS using fNIRS 2Walking fish reveal how our ancestors evolved onto land 2
... is a mystery. Butterfly or baby, cells organize themselves ... and over, patterns emerge in all living creatures. Spiders ... encased in an elegant spiral shell. , This phenomenon ... the forces that govern it are far from clear. ...
... team who - 10 years ago - created the ... Association of Pharmaceutical Scientists' (AAPS) National Biotechnology Conference in ... of the world's leading scientists will discuss a variety ... field that is being hailed as the next revolution ...
... soil can transform the most commonly used flame retardant compound ... be harmful to humans, according to a new laboratory study ... Society journal, Environmental Science & Technology . The study ... of the journal. , The finding, by a team of ...
Cached Biology News:The shape of life: research sheds light on how cells take shape 2Ten years later, Dolly is still making headlines 2Microbes transform 'safest' PBDEs into more harmful compounds 2
... Edited by N.C. Price (1996) ... information on protein chemistry and ... of proteins. Data on the ... crystalization, size determination, amino acid ...
Edited by D.M. Gersten (1996) Provides comprehensive descriptions of the techniques available for analytical gel electrophoresis of proteins and offers clear step-by-step protocols for all of the m...
...
All serum is collected from U.S.D.A. fryers and broilers. Pricing: $15/unit for 1 - 10 units; $12/unit for 11 - 50 units...
Biology Products: