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 behavioral issues in children and adolescents. The CPRS-R assessments 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).


'/>"/>

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

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:10/13/2017)... ... 2017 , ... The Visiting Nurse Association (VNA) of Somerset Hills is proud ... and unique items from across the nation, this holiday-themed event will raise funds and ... the VNA. The boutique will be open Saturday, November 4 (10:00 a.m. – ...
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House ... most popular and least understood books in the Holy Scriptures, Revelation. The Book of ... baffled scholars for centuries. Many have tossed it off as mere rubbish, but Yisrayl ...
(Date:10/13/2017)... ... ... Journey: From the Mountains to the Mission Field”: the story of a missionary couple ... From the Mountains to the Mission Field” is the creation of published author, Carole ... and currently teaches a class of ladies at her church, which she has taught ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... sleep apnea using cutting-edge Oventus O2Vent technology. As many as 18 ... characterized by frequent cessation in breathing. Oral appliances can offer significant relief to ...
(Date:10/12/2017)... ... October 12, 2017 , ... IsoComforter, Inc. ( ... today the introduction of an innovative new design of the shoulder pad. The ... get maximum comfort while controlling your pain while using cold therapy. By utilizing ice ...
Breaking Medicine News(10 mins):
(Date:10/10/2017)... 10, 2017   West Pharmaceutical Services, Inc. ... injectable drug administration, today shared the results of a ... improving the intradermal administration of polio vaccines. The study ... in May 2017 by Dr. Ondrej Mach , ... Health Organization (WHO), and recently published in the journal ...
(Date:10/4/2017)... Mass. , Oct. 4, 2017  According to the Centers for ... the end of October . PhysicianOne Urgent Care is helping communities across ... Westchester, NY , by offering no-cost* flu shots through the ... as mandated by certain health insurance regulations. ... The best time to get a flu shot is by the ...
(Date:10/2/2017)... 2017  AllianceRx Walgreens Prime, the combined central specialty ... pharmacy benefit manager Prime Therapeutics LLC (Prime), today officially ... the unveiling of new signage at its headquarters in ... at a few other company-owned facilities across the country. ... some of whom will begin to see the AllianceRx ...
Breaking Medicine Technology: