Navigation Links
Shire's Investigational Nonstimulant ADHD Treatment INTUNIV(TM) (Guanfacine Extended Release) Demonstrated Significant Efficacy in Reducing ADHD Symptoms at All Measured Time Points Up to 24 Hours Postdose
Date:5/7/2008

sments were completed on specified days at approximately 6 PM (after school and before dinner), 8 PM (dinner through bedtime) and 6 AM (waking time/new dose administration time), which represented 12, 14 and 24 hours after the administration of the dose of INTUNIV, respectively. The data demonstrated significant improvement of ADHD symptoms based on total endpoint CPRS-R scores for all weight adjusted dose groups treated with INTUNIV when compared to placebo for all time periods (at 12 hours, P=<.001; at 14 hours, P<.001; and at 24 hours, P=.003).

A separate analysis of the same phase III studies evaluated the percentage of ADHD patients who responded to weight-adjusted treatment with INTUNIV versus those participants receiving placebo. Using the change in the ADHD-RS-IV total score from baseline to endpoint as the primary efficacy measure, responders were defined as those with a 25 percent reduction in score from baseline to endpoint. Findings from the analysis showed that all groups treated with INTUNIV responded to the medication in a shorter time period than the placebo group (14 days versus 20 days, respectively, P=.001).

In the phase III studies, adverse events (AEs) were reported in 80.7 percent of patients treated with INTUNIV and 71.8 percent of patients treated with placebo. Overall, the AEs were mostly mild to moderate in severity. Adverse reactions that appeared to be dose-related in patients given INTUNIV included upper abdominal pain, constipation, dizziness, dry mouth, hypotension, sedation, and somnolence. Serious AEs reported in these analyses were uncommon and rates were similar between patients treated with INTUNIV and patients treated with placebo (0.6% of the INTUNIV group and 0.7% of placebo group, respectively).

About INTUNIV

INTUNIV, a once-daily formulation of guanfacine, provides a controlled, steady delivery of drug throughout the day with a delivery system that is designed to minimize the fluctuations between p
'/>"/>

SOURCE Shire plc
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Pharmacopeia Announces Upcoming Late-Breaker Presentation of Phase 2a Results for Its First-in-Class Investigational DARA Compound, PS433540
2. Abbotts Phase III Studies of Investigational TriLipix(TM) (ABT-335), in Combination With Statins, Meets Primary Endpoints on Improving LDL, Triglycerides and HDL
3. Study Results Show Investigational Drug, Prasugrel, Cuts Risk of Stent-Related Clots by More than Half Versus Clopidogrel
4. FDA Accepts Investigational New Drug Application for ARI-2243 and a First in Man Clinical Trial Set to Begin During the First Half of 2008
5. Medarex Announces Allowance of Investigational New Drug Applications for Wholly Owned Fully Human Anti-CD19 Antibody, MDX-1342
6. AstraZeneca Completes Enrollment in First Phase III Study of the Investigational Drug Vandetanib (ZACTIMA)(R) in Non-Small Cell Lung Cancer
7. Lexicon Files Investigational New Drug Application for LX2931 as a Potential Treatment for Rheumatoid Arthritis
8. SCH 530348 (TRA), a Novel Investigational Antiplatelet Agent, Shown to Inhibit Platelet Aggregation in PCI Patients
9. Roches Investigational Polymerase Inhibitor, Combined with PEGASYS(R) and COPEGUS(TM), Shows Potent Antiviral Activity in Treatment of Chronic Hepatitis C at Four Weeks
10. Lexicon Reports Initial Clinical Trial Results for LX1031, an Investigational New Drug for Irritable Bowel Syndrome
11. KineMed Presents Preclinical Data for Investigational Agent Demonstrating Neurogenesis and Confirming Improvements in Behavioral Model
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/26/2014)... , Nov. 25, 2014  goBalto, Inc., the leading ... recognized as a winner of Red Herring,s Top ... Top 100 North America award in 2013, marking its ... landscape. Red Herring,s Top 100 Global list ... new companies and entrepreneurs. Red Herring editors were among ...
(Date:11/26/2014)... , Nov. 25, 2014 Nanomix ... on the development of mobile diagnostic tests ... in hospital and pre-hospital settings, today announced ... 13485:2003 certification.  The certification was awarded by ... the world,s leading certification bodies. ...
(Date:11/26/2014)... Nov. 25, 2014  Array BioPharma Inc. ... that its Chief Executive Officer, Ron ... upcoming conferences.  The public is welcome to ... the Array BioPharma website:  www.arraybiopharma.com .Event: Piper ... p.m.  Eastern Time Location: Palace Hotel, New ...
Breaking Medicine Technology:goBalto Selected as a 2014 Red Herring Top 100 Global Company 2goBalto Selected as a 2014 Red Herring Top 100 Global Company 3Nanomix Receives ISO 13485:2003 Certification 2
... YORK, May 21, 2012  Delcath Systems, Inc. (Nasdaq: ... to shareholders at the Company,s annual stockholder meeting on May ... in New York City. The presentation will commence at approximately ... webcast and view slides of the presentation during or after ...
... InfuSystem Holdings, Inc. (NYSE MKT: INFU) ("InfuSystem" or the ... services, today announced that it received a letter from ... of the "record date" for the 2012 Annual Stockholders, ... record date for the Company,s 2012 Annual Meeting, meaning ...
Cached Medicine Technology:Delcath to Webcast Management's Presentation at Annual Meeting of Stockholders 2Delcath to Webcast Management's Presentation at Annual Meeting of Stockholders 3InfuSystem Holdings, Inc. Receives Letter From NYSE MKT Regarding Timely Notice Of Record Date For 2012 Annual Meeting Of Stockholders 2
(Date:11/26/2014)... OR (PRWEB) November 26, 2014 The ... fresh water shortages, is moving forward with a plan ... drinking water.* Radio host Sharon Kleyne supports the San ... “Total Water Management” (TWM). According to Kleyne, by recycling ... constantly import new water could be greatly reduced. (Spagat, ...
(Date:11/26/2014)... November 26, 2014 With a redesign ... Dr. Steven Meier has enhanced the user experience ... and prospective patients an online destination for orthopedic and ... to present the new and improved version of the ... it easier than ever for current and prospective patients ...
(Date:11/26/2014)... November 26, 2014 Senior Planning Services, ... SeniorNet, a nonprofit organization providing the adult demographic ... to help seniors navigate the rough seas of applying ... educating seniors on the topic of Medicaid eligibility and ... complicated process of applying for this coverage. , ...
(Date:11/26/2014)... (PRWEB) November 26, 2014 Anthropologists ... effectiveness in containing and stopping Ebola, improve international ... in healthcare systems in West Africa. , ... to Stop Ebola: Anthropologists Offer Insights,” will be ... the American Anthropological Association (AAA), Fri., Dec. 5, ...
(Date:11/26/2014)... November 26, 2014 Bunion Bootie, the ... prices in an early celebration of the early holiday ... being offered at the promotional price of $29.95 each ... in addition to any automatic discounts applied when buying ... Bootie website for complete details. It’s simple: purchasing ...
Breaking Medicine News(10 mins):Health News:Global fresh water advocate supports San Diego wastewater recycling plan 2Health News:Global fresh water advocate supports San Diego wastewater recycling plan 3Health News:Los Angeles Orthopedic Surgeon Dr. Steven Meier Announces Relaunch Of Practice Website 2Health News:Senior Planning Services Teams Up with SeniorNet To Educate Seniors On Medicaid Planning 2Health News:Anthropologists Release Recommendations, Better Practices to Contain Ebola 2Health News:Anthropologists Release Recommendations, Better Practices to Contain Ebola 3Health News:Bunion Bootie Temporarily Lowering Prices for Holiday Shopping, Starting Today! 2
... Scripps ... from the American Nurses Credentialing Center (ANCC). , ... La Jolla, CA (Vocus) June 16, 2010 -- ... excellence from the American Nurses Credentialing Center (ANCC). , , , , ,The new ...
... a majority of cases, due to late diagnosis of the ... Biodesign Institute at Arizona State University, along with Arturo Ramirez ... Center in Seattle, used a novel method for identifying ... appear. The work, which appeared recently in the ...
... ... for everyone: Protect your PC and files at home with free ... of portable storage devices (USB Flash Drives, external hard drives, digital ... and MACs,• Free data loss and theft protection for home and individual ...
... (ASTRO) continued to advance its Target Safely initiative by ... meeting on Device Improvements to Reduce the Number of ... June 9 and 10. ASTRO commends the FDA on ... develop data, which will help inform the FDA,s actions ...
... drug abuse, study finds , WEDNESDAY, June 16 (HealthDay News) ... abuse treatment have nearly doubled between 1992 and 2008, a ... and/or marijuana abuse among men and women aged 50 and ... 12 percent by 2008, according to researchers from the U.S. ...
... in French . , Montreal, June 16, ... Research in Immunology and Cancer (IRIC) of the Universit de ... three cancer-causing genes in acute lymphoblastic leukemia. Published in the ... on the complex interaction between the genes and their contributions ...
Cached Medicine News:Health News:Scripps Memorial Hospital La Jolla First in San Diego to Achieve Magnet Nursing Re-designation 2Health News:Scripps Memorial Hospital La Jolla First in San Diego to Achieve Magnet Nursing Re-designation 3Health News:Blood relations 2Health News:Blood relations 3Health News:My Endpoint Protector Device Control is Now Available for Home Users Free of Charge 2Health News:My Endpoint Protector Device Control is Now Available for Home Users Free of Charge 3Health News:My Endpoint Protector Device Control is Now Available for Home Users Free of Charge 4Health News:'Graying' of Drug Users at U.S. Treatment Centers 2Health News:Montreal researchers shed light on common juvenile cancer 2
... new age of non-surgical facial contouring materials. ... long-term results for various applications with exceptional ... superior versatility for a wide variety of ... saves time and money for both you ...
... Response is a whole blood ... be used at the point-of-care. ... screen and data management features, ... options. QC and operator lockout ...
... a revolutionary scientific breakthrough for controlling unsightly ... Cream permits you to spot reduce in ... can rid yourself of those unwanted lumps ... to your thigh, waist, tummy, or chin ...
... has been developed specifically to fight Cellulite ... and hips. It does this by stimulating ... fluids in your body, which then are ... daily, for about 15 minutes each treatment. ...
Medicine Products: