Navigation Links
Shire investigational nonstimulant INTUNIV showed significant efficacy in reducing ADHD symptoms
Date:5/7/2008

WASHINGTON, May 7 -- Shire plc(LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, presented today at a major scientific meeting findings from analyses of pivotal trial results of INTUNIV, a selective alpha-2A-agonist. This compound is an investigational once-daily medication, which is being evaluated for the treatment of the symptoms of Attention Deficit Hyperactivity Disorder (ADHD). The data demonstrated that INTUNIV showed significant efficacy in reducing ADHD symptoms for patients taking the medication when compared to patients taking placebo at all measured time points up to 24 hours postdose.

The U.S. Food and Drug Administration (FDA) issued an approvable letter on June 20, 2007, regarding INTUNIV. Shire is conducting additional clinical work which is designed to enhance the label. Upon approval, INTUNIV will be the first selective alpha-2A receptor agonist indicated for the treatment of ADHD that may provide an important treatment option for patients and physicians.

Summary of Analyses

The pooled analysis evaluated results from these patients on a weight adjusted mg/kg basis from two similarly designed, randomized, double-blind, forced-dose titration, multicenter phase III trials. The primary efficacy measure for both studies was change in the ADHD Rating Scale (ADHD-RS-IV) total score from baseline to endpoint. All patient groups treated with INTUNIV showed significantly greater improvement in ADHD-RS-IV total score from baseline to endpoint than the placebo group (P < .001). The ADHD-RS-IV is a standardized, validated test for assessing symptoms of ADHD and for assessing their response to treatment.

The analysis also studied duration of effect using the Conners' Parent Rating Scale-Revised Short Form (CPRS-R), which is a comprehensive scale that used observer and self-report ratings to help assess ADHD and evaluate be
'/>"/>

Contact: MIchelle Park
212-601-8248
Porter Novelli
Source:Eurekalert

Page: 1 2

Related medicine news :

1. Anthem Blue Cross and Blue Shield in New Hampshire Announces Unique Enhancement to its ePrescribing Program
2. Shire to present ADHD treatments scientific data at American Psychiatric Assoc. Meeting
3. AUDIO from Medialink and Shire: What It Means to be an Adult With ADHD
4. Shire Launches Patient Education Forums on Better Managing the Challenges of Ulcerative Colitis
5. VIDEO from Medialink and Shire plc: Rare Diseases Must Be Top of the Health Agenda
6. New Hampshire AIDS Group Calls on Huckabee to Disavow His 1992 Statement
7. Shire to Present New Scientific Data on its ADHD Treatments at a Major Psychiatric Meeting
8. New Hampshire: 1st in the Nation Primary State Takes a Stand on E-Prescribing
9. Families Invited to Celebrate Shire Day at Boston Childrens Museum
10. URAC CEO Testifies Before New Hampshire Legislators Regarding New URAC Standards for Pharmacy Benefit Management
11. Exciting New Plan from John Edwards on AIDS; Plan is Bold and Achievable, say New Hampshire Activists
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/9/2014)... Susan Wakulich was told she had an aneurysm, she figured ... her. , "I was devastated," said Wakulich, who is 56 ... this was a serious diagnosis. Then I met Dr. Bernard ... a less invasive procedure. It was something I didn,t even ... a multi-center U.S. clinical trial to evaluate the safety and ...
(Date:7/9/2014)... Fox Chase Cancer Center paint a relatively optimistic picture ... cancers that have spread to the chest wall or ... into the skin, regardless of size and whether they ... III and called "locally advanced" tumors, suggesting that ... with poor survival. Locally advanced breast cancers of this ...
(Date:7/9/2014)... release is available in French . ... in 14 year old teens, including brain structure and function, ... accuracy who will go on to develop binge drinking within ... conscientiousness, and other variables such as life events and a ... binge drinking. Whether or not the child had had ...
(Date:7/9/2014)... It may smell of flatulence and have a reputation for ... dosage, hydrogen sulfide is now being being found to offer ... to stroke, heart attacks and dementia. A new compound (AP39), ... the key to future therapies, by targeting delivery of very ... places inside cells. , Scientists in Exeter have already ...
(Date:7/9/2014)... with kidney and heart disease have raised concerns about ... However, in the first study to look closely at ... at the University of Pennsylvania report that older kidney ... and cardiovascular health as very healthy older people who ... ever increasing organ transplant waitlists, the authors of the ...
Breaking Medicine News(10 mins):Health News:New type of stent could help some brain aneurysm patients 2Health News:Fox Chase researchers recommend updating the staging criteria for breast cancer diagnoses 2Health News:Fox Chase researchers recommend updating the staging criteria for breast cancer diagnoses 3Health News:What drives a child to abuse alcohol? 2Health News:Rotten egg gas holds key to healthcare therapies 2Health News:Penn study finds living kidney donation does not increase risk of death or heart disease for older 2
... of fruit and vegetables are less likely to develop ... with chronic obstructive pulmonary disease (COPD) are smokers or ... COPD - so there must be influences that mitigate ... ,Researchers at the University of Southampton, UK, have ...
... consume wine in moderation have healthier lifestyles overall than abstainers ... well established that moderate alcohol consumption seems to confer ... of heart disease. A new study shows that it may ... produce at least some of the beneficial effects. ...
... that doctors know the power of a common heart medication ... many patients do not take the medications. Research shows the ... the risk of early death by 20 percent. However, many ... dysfunction and, therefore, do not take the drugs. A new ...
... the most widely spread cancer all over the world. ... expected to die from breast cancer this year. Researchers ... be an important factor fueling this ever-growing epidemic.// ... 25 countries that included information on breastfeeding and childbearing ...
... A commonly used antidepressant may help women who suffer ... citalopram, marketed as Celexa, may help women who have ... from the University of Pennsylvania Medical Center in Philadelphia, ... would work. Half-cycling means the medication is started 14 ...
... According to a new research, a daily dose of a ... the "bad", or LDL, cholesterol levels in young men. Functional ... supplying essential nutrients. //There has been a trend of adding ... healthier. For example, Benecol Spread is a margarine that contains ...
Cached Medicine News:Health News: Breastfeeding may decrease Breast Cancer Risk 2
(Date:1/15/2014)... 2014 Reportlinker.com announces that a new ... catalogue: Global Markets ... -- Focus on End Users ... A drug delivery system is ...
(Date:1/15/2014)...  A novel wearable injector slightly larger than an Oreo cookie ... self-inject prescription drugs in the large doses required to treat ... deficiencies, and genetic disorders.  An emerging biologic ... according to analysts.   Many of these drugs will require a ...
(Date:1/14/2014)... , Jan. 14, 2014 InformEx, North ... sellers of high-value chemistry, will hold the 30 th ... Beach Convention Center from January 21-24. ... attendees from top pharmaceutical, fine chemical and specialty chemical companies ...
Breaking Medicine Technology:Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 2Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 3Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 4Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 5Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 6Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 7Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 8Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 9Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 10Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 11Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 12Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 13Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 14Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 15Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 16Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 17Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on End Users 18Enable Injections Presents A New Class of Injectors for Drug Delivery at PEPTalk, Drug Delivery Partnership Meetings 2Media Advisory: InformEx 2014 Events & Speaker Lineup for 30th Edition Conference in Miami Beach 2
... YORK, Feb. 17, 2011 Reportlinker.com ... report is available in its catalogue: ... 2016 - Cephalosporins, Penicillins, Macrolides and ... http://www.reportlinker.com/p0397051/Anti-Bacterials-Market-to-2016---Cephalosporins-Penicillins-Macrolides-and-Fluoroquinolones-to-Drive-the-Anti-Bacterials-Market.html ...
... Reportlinker.com announces that a new market research ... Early Stage Drug Discovery in Disease Segments ... Gene Therapies http://www.reportlinker.com/p0397053/Early-Stage-Drug-Discovery-in-Disease-Segments---Innovation-Focuses-on-Stem-Cell-Therapies-and-Gene-Therapies.html ... Segments - Innovation Focuses on Stem Cell Therapies ...
Cached Medicine Technology:Reportlinker Adds Anti-Bacterials Market to 2016 - Cephalosporins, Penicillins, Macrolides and Fluoroquinolones to Drive the Anti-Bacterials Market 2Reportlinker Adds Anti-Bacterials Market to 2016 - Cephalosporins, Penicillins, Macrolides and Fluoroquinolones to Drive the Anti-Bacterials Market 3Reportlinker Adds Early Stage Drug Discovery in Disease Segments - Innovation Focuses on Stem Cell Therapies and Gene Therapies 2Reportlinker Adds Early Stage Drug Discovery in Disease Segments - Innovation Focuses on Stem Cell Therapies and Gene Therapies 3Reportlinker Adds Early Stage Drug Discovery in Disease Segments - Innovation Focuses on Stem Cell Therapies and Gene Therapies 4
... PCA Peel® formula, this peel will ... exfoliation for oilier, thicker and more ... on extremely sun damaged and thickened ... those with active/cystic acne and asphyxiated ...
It works by stimulating new growth of skin and collagen by decreasing the bond that holds dead skin cells on the surface. This allows dead cells to be removed gradually, leaving behind a layer of smo...
... LipiVage™ Fat Harvest, Wash & Transfer System ... to make fat transfer procedures simpler for ... satisfy the need for an office-based technique. ... There is no longer a need to ...
... BOTOX® Cosmetic is a simple, nonsurgical, physician-administered ... severe frown lines between the brows in ... age. It is the only treatment of ... Drug Administration (FDA). BOTOX® Cosmetic is ...
Medicine Products: