Navigation Links
Shire announces publication of open-label study on coadministration of INTUNIV with stimulants

PHILADELPHIA November 16, 2009 Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced new study results on INTUNIV (guanfacine) Extended-Release Tablets published in the October Journal of Child and Adolescent Psychopharmacology. In this open-label safety study, there was no evidence of unique adverse effects with the combination of INTUNIV and amphetamine or methylphenidate relative to what was observed with either medication alone. The open-label study also assessed improvement of Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms using the ADHD Rating Scale-IV (ADHD-RS-IV). INTUNIV is a nonscheduled, once-daily selective alpha-2A agonist indicated for monotherapy treatment of ADHD in children and adolescents ages 6 to 17.

"Pivotal studies have shown that INTUNIV improved ADHD symptoms in children and adolescents with the disorder, and the publication of these safety data gives us insight into administering INTUNIV in combination with stimulant medications in the management of ADHD," said Andrew J Cutler, MD, courtesy assistant professor, department of psychiatry, University of Florida, and CEO and medical director, Florida Clinical Research Center, Bradenton, FL. "This study helped inform the design of a controlled coadministration trial of INTUNIV with stimulant medications, which Shire is currently conducting."

An estimated 25 to 30 percent of ADHD patients may not respond to the most commonly prescribed ADHD medications, methylphenidates and amphetamines, when used alone as ADHD treatment.

About the Coadministration Study

This nine-week, open-label, multicenter, dose-escalation study assessed the safety and effectiveness of coadministering INTUNIV with stimulant medications (methylphenidate or amphetamine). The enrolled patient population included 75 children and adolescents ages 6 to 17 diagnosed with ADHD whose ADHD symptoms were suboptimally controlled after at least one month of treatment with these stimulants. Investigators then started subjects at 1 mg/day of INTUNIV and increased the dose each week by 1 mg to the highest tolerated dose (1 mg/day, 2 mg/day, 3 mg/day, or 4 mg/day). Throughout the INTUNIV titration and maintenance phases of the study, subjects remained on the current dose of their stimulant medication.

The study met its primary objective which was to evaluate the safety of coadministration of INTUNIV (up to 4 mg/day) with stimulants. The study safety assessments included adverse events (AEs), vital signs, electrocardiogram (ECG) readings, physical examination, clinical laboratory tests, the Pediatric Daytime Sleepiness Scale (PDSS), and the Pittsburgh Side Effects Rating Scale (PSERS). AEs were generally mild to moderate. The most common treatment-emergent AEs seen with coadministration (>10.0 percent) were fatigue (34.7 percent), headache (33.3 percent), upper abdominal pain (32.0 percent), irritability (32.0 percent), somnolence (18.7 percent), and insomnia (16.0 percent). The most common treatment-emergent AEs that investigators deemed were possibly related or related to INTUNIV when given with either stimulant were upper abdominal pain (25.3 percent), fatigue (24.0 percent), irritability (22.7 percent), headache (20.0 percent), somnolence (18.7 percent), and insomnia (13.3 percent). Similar proportions of both treatment groups (INTUNIV and amphetamine or INTUNIV and methylphenidate) experienced these treatment-emergent AEs. Blood pressure decreases, though frequent, were rarely rated by investigators as AEs: two subjects (2.7 percent) had decreased blood pressure and one (1.3 percent) had unspecified hypotension. There were no serious AEs or deaths.

Furthermore, coadministration of INTUNIV with methylphenidate or amphetamine did not increase sleepiness, as noted by the decrease in PDSS scores assessed at visit six and at the end of the study.

Study results also demonstrated statistically significant mean changes from baseline (stimulant monotherapy just prior to receiving INTUNIV) to end point in ADHD-RS-IV total scores. Secondary efficacy end points included subjects' scores on the Conners' Parent Rating Scale-Revised Short Form (CPRS-R), Clinical Global Impression-Severity and Improvement scales (CGI-S and CGI-I), Parent Global Assessment (PGA) scale, and Child-Health Questionnaire-Parent Form (CHQ-PF50).

INTUNIV is not approved for coadministration with other ADHD medications.


Contact: Matt Cabrey
Porter Novelli

Related medicine news :

1. Shire reports analysis examining emotional lability in children with ADHD taking Vyvanse
2. Shire Reports Findings From an Analysis Examining Emotional Lability in Children With ADHD Taking Vyvanse(R) (lisdexamfetamine dimesylate) Capsules CII
3. Anthem Blue Cross and Blue Shield in New Hampshire Announces Decision to Cover H1N1 Vaccine Administration
4. Yorkshire and Humber NHS Procurement Hub Selects BigHand Voice Platform
5. Anthem Blue Cross and Blue Shield in New Hampshire, Elliot Hospital Announce Renewed Contract, Quality Initiative
6. AspireHR Completes Phase 1 SAP HR Initiative for Shire Pharmaceuticals
7. Anthem Blue Cross and Blue Shield in New Hampshire Gives Boost to Help Small Businesses in the Granite State
8. VA Awards $3.7 Million for New Hampshire Veterans Home
9. Shires INTUNIV (Guanfacine) extended release in children with ADHD and oppositional symptoms
10. Shire Expands Gastrointestinal Patient Assistance Program for Uninsured or Unemployed Americans
11. Shire to Present New Scientific Data on its ADHD Treatments at a National Scientific Meeting of Psychiatrists on May 18
Post Your Comments:
(Date:11/27/2015)... ... November 27, 2015 , ... A team of Swiss doctors has released a ... Mesothelioma has just posted the findings on the website. Click here to read ... of 136 mesothelioma patients who were treated with chemotherapy followed by EPP surgery. Among ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... 27th edition of USA Today in Atlanta, Dallas, New York, Minneapolis, South Florida, ... The digital component is distributed nationally, through a vast social media strategy and ...
(Date:11/27/2015)... ... November 27, 2015 , ... Intellitec Solutions announced ... User Group (MSDSLUG). Recognized as Microsoft’s official group for end users of Dynamics ... software users, partners, industry experts and representatives. Intellitec Solutions’ membership status demonstrates their ...
(Date:11/27/2015)... ... November 27, 2015 , ... CBD College ... Allied Health Education Programs (CAAHEP) awarded accreditation to its Diagnostic Medical Sonography program. CBD ... colleges, as only one of twelve colleges and universities in the state of California ...
(Date:11/27/2015)... ... 27, 2015 , ... Indosoft Inc., developer and distributor of ... 11 LTS (Long Term Support) into its Q-Suite 5.10 product line. , Making ... with a version of Asterisk that will receive not only security fixes, but ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... , November 26, 2015 ... A new combination approach blends immunotherapy with Bremachlorin-photodynamic therapy ... new combination approach blends immunotherapy with Bremachlorin-photodynamic therapy for ... new combination approach blends immunotherapy with Bremachlorin-photodynamic therapy for ... has found that immunotherapy can be efficiently ...
(Date:11/26/2015)... 2015 Research and Markets ( ... "2016 Future Horizons and Growth Strategies in the ... Country Segment Forecasts, Competitive Intelligence, Emerging Opportunities" ... --> --> This new 247-page ... therapeutic drug monitoring market, including emerging tests, technologies, ...
(Date:11/26/2015)... DUBLIN , Nov. 26, 2015 Research ... of the "Advanced Wound Care Market by Type ... Ulcers), End User (In-Patient Facility, Out-Patient Facility), and Geography ... offering. --> --> ... the description, definition and forecast of the global advanced ...
Breaking Medicine Technology: