Navigation Links
Shire Announces FDA Approval of Once-Daily INTUNIV(TM) (guanfacine) Extended Release Tablets for the Treatment of ADHD in Children and Adolescents Aged 6 to 17
Date:9/3/2009

asured were: inattentiveness/being easily distracted, running around or climbing excessively, arguing with adults, losing temper, and interrupting or intruding on others. Significant improvements were seen on both scales: based on the CPRS-R, parents reported significant improvement across a full day (as measured at 6 pm, 8 pm, and 6 am the next morning); based on the CTRS-R, which was used only in the first pivotal trial, teachers reported significant improvement throughout the school day (as measured at 10 am and 2 pm).

Investigators also measured the efficacy of INTUNIV with the Clinical Global Impressions-Improvement (CGI-I) scale, a standard assessment used to rate the improvement of a patient's illness over the course of the study. The first pivotal trial found the percentage of subjects taking INTUNIV who were rated "much improved" or "very much improved" at end point ranged from approximately 50 to 56 percent across all doses versus approximately 26 percent for placebo (P<.05). Subjects taking INTUNIV in the second pivotal trial who rated "much improved" or "very much improved" at end point ranged from 54 to 56 percent across 1-mg (P=.0070), 3-mg (P=.0060), and 4-mg (P=.0040) doses versus 30 percent for placebo; the placebo-INTUNIV difference for the 2-mg dose was not significant (P=.1404).

Safety was also evaluated during these pivotal trials and safety data showed that adverse events reported by participants using INTUNIV were generally mild to moderate in severity, with the most common side effects being sedative in nature. Sedation-related, treatment-emergent adverse events were among the most common and were usually transient and mild to moderate in severity. Treatment-related adverse events greater than 10 percent included somnolence (32 percent), headache (26 percent), fatigue (18 percent), upper abdominal pain (14 percent), and sedation (13 percent). Small to modest changes in blood pressure, pu
'/>"/>

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

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. Shire Strives to Increase Adherence Among Chronic Kidney Disease Stage 5 Patients
2. Shire Enhances its Orphan Drug Pipeline With the Acquisition of a New Clinical Candidate for Metachromatic Leukodystrophy
3. Shire to Present Additional Scientific Data on ADHD Treatment Portfolio at American Psychiatric Association Annual Meeting
4. Shires 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
5. Shire Announces Approval of ELAPRASE(R) (idursulfase) in Brazil
6. Shire to add New Orphan Drug to its HGT Portfolio - EU Launch Imminent
7. Shire Withdraws European Application for DAYTRANA(TM) (Methylphenidate Transdermal System)
8. Shire Announces Study Results of the Effects of INTUNIV(TM) (Guanfacine) Extended Release on Secondary Measures in Children with ADHD and Oppositional Symptoms
9. Shire Presented Results of a New Database Analysis on Lialda(R) (Mesalamine) and Other 5-ASAs for Ulcerative Colitis at Digestive Disease Week
10. Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease
11. Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2014)... 2014  Publicis Groupe customer engagement agency ... and Healthcare Industry Group Leader, has been featured in ... most inspiring people in the life-sciences industry. Those chosen ... development, marketing, technology, creativity, strategy and medicine. ... partner in its leading Rosetta Consulting practice. In 2012, ...
(Date:8/21/2014)... Aug. 21, 2014  Decision Resources Group finds ... Brazil and ... and commonly prescribe long-acting beta-agonist (LABA)- and long-acting ... so within current severe cost/coverage constraints. Therefore, new ... expected to launch in these countries—which will considerably ...
(Date:8/21/2014)... 21, 2014 /PRNewswire-iReach/ -- ScriptPro has been certified ... its Common Security Framework (CSF). According to ... Manager, "We appreciate this rigorous, top-to-bottom audit. Security-minded ... this certification signifies. Our business partners need to ... CSF CERTIFICATION PROCESS: ScriptPro,s internal security processes and ...
Breaking Medicine Technology:Shannon Hartley Shines in PharmaVOICE 100 2Novel Fixed-Dose Combinations for COPD in Brazil and Mexico Will Compete With Well-Established Therapies in an Environment Dominated by Aggressive Cost-Control Mechanisms 2Novel Fixed-Dose Combinations for COPD in Brazil and Mexico Will Compete With Well-Established Therapies in an Environment Dominated by Aggressive Cost-Control Mechanisms 3ScriptPro Achieves HITRUST Certification 2
... Johnson & Johnson (NYSE: JNJ ) today ... & Diagnostics (MD&D) and Sheri McCoy, currently Worldwide Chairman, ... Committee and join William C. Weldon, Chairman of the ... of the Chairman.  Both appointments are effective January 3, ...
... LAKE FOREST, Ill., Dec. 15, 2010 RoundTable ... focused exclusively on the healthcare industry, announced today ... to sell one of its portfolio companies, Clinical ... private investment firm representing Pritzker family interests.  Terms ...
Cached Medicine Technology:Johnson & Johnson Announces Executive Appointments: Alex Gorsky, Vice Chairman, Executive Committee Sheri McCoy, Vice Chairman, Executive Committee 2Johnson & Johnson Announces Executive Appointments: Alex Gorsky, Vice Chairman, Executive Committee Sheri McCoy, Vice Chairman, Executive Committee 3RoundTable Healthcare Partners Announces Sale of Clinical Innovations, LLC to The Pritzker Group 2
(Date:8/22/2014)... Bcl-2-like protein 11 (BIM) deletion in advanced ... shorter progression free survival (PFS) in epidermal growth ... chemotherapy treated Asian patients. Also, BIM deletion independently ... , The BIM protein can activate the programmed ... in cells. BIM deletion has been detected in ...
(Date:8/22/2014)... Rheumatoid arthritis (RA), a complex autoimmune disease that ... patients to not only cope with pain, disability ... as disrupted work, family life and marital functioning. ... residual pain and disability is common. In addition, ... high cost or side effects. Because of this, ...
(Date:8/22/2014)... (PRWEB) August 22, 2014 Advancements ... for some clinical applications due to their cost-effectiveness, ... emerging innovations in ultrasound, such as the evolution ... expected to keep the market moving throughout 2014 ... mobility can enhance not only the point-of-care (POC) ...
(Date:8/22/2014)... Sac, Wisconsin (PRWEB) August 22, 2014 ... System for Plantar Fasciitis, an exciting new product that ... allows you to stay active while you heal. The ... This is truly a new technology – it is ... affordable. , FasciaDerm® PFTape™ System for Plantar Fasciitis ...
(Date:8/22/2014)... intensive effort to sterilize feral cats reduced the number of ... a new study reveals. "We investigated whether we ever ... control," Dr. Julie Levy, a professor of shelter medicine at ... a university news release. "Neutering a few cats ... "so we wanted to pick a focused area and throw ...
Breaking Medicine News(10 mins):Health News:Deletion predicts survival in advanced non-small cell lung cancer 2Health News:Study shows cognitive-behavioral coping skills training has positive effects on rheumatoid arthritis 2Health News:Global Top Ultrasound Market Suppliers Assessed in New VPG Research Report Available at MarketPublishers.com 2Health News:Global Top Ultrasound Market Suppliers Assessed in New VPG Research Report Available at MarketPublishers.com 3Health News:Mueller Introduces FasciaDerm® PFTape™ System for Plantar Fasciitis 2Health News:Neutering Project Curbed Feral Cat Population 2
... a potential heart attack risk? According to a recent study, ... with the strengthening of the US economy., ,Christopher Ruhm, ... Greensboro wrote in his study that there is a pronounced ... economy grows further with no improvement in the rate of ...
... to a study conducted by the University of Erfurt ... willing to inflict financial pain to achieve// collective gain. ... ,Researchers have found that groups in ... were more popular than groups without this option. Though ...
... According to experts approximately 6,000 plus trampolining fractures were ... for new safety guidelines// are needed to stem the ... in a study has found a "worrying trend" in ... in the home. ,The Royal Berkshire in ...
... doesn’t seem to have learnt its lessons yet, because there ... of AIDS/HIV//. Next only to South Africa with the highest ... million mark as per statistics in 2003, very little has ... AIDS/HIV cases, according to Prof Suzanne Crowe, Deputy Chairperson of ...
... Pharma has come up with a new neupro skin patch ... It is said to offer relief to patients// in the ... mimics the effects of a naturally occurring brain chemical, which ... ,The Parkinson's Disease Society said that the patch would aid ...
... It’s learning time for countries, and Vietnam’s tryst with ... management//. Vietnamese Farmers appear to know much more about ... their counterparts in Europe and Africa. Not surprising, since ... the onslaught of bird-flu, which in 2003 had claimed ...
Cached Medicine News:Health News:Competitive Advantage Are Attained In Which Freeloaders Are Punished 2Health News:Competitive Advantage Are Attained In Which Freeloaders Are Punished 3Health News:Competitive Advantage Are Attained In Which Freeloaders Are Punished 4Health News:Be cautious while on the Trampoline 2
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: