Navigation Links
Shionogi Announces FDA Approval of KAPVAY™ - The First and Only Therapy Approved for Use with Stimulant Medication for the Treatment of ADHD
Date:10/4/2010

VAY™, when added to a stimulant, addresses an unmet need, and improves ADHD symptoms beyond what is achieved by stimulants alone. This is a significant step forward for the treatment of ADHD to have an approved product for add-on therapy in our treatment armamentarium."

ADHD is a neurobehavioral disorder that occurs in childhood and may continue into adolescence and adulthood, which affects more than 4.5 million children ages 3-17 in the U.S. alone. Approximately 3-7 percent of U.S. school-aged children are believed to suffer from this disorder. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior, and hyperactivity/over-activity.

This approval is based on two Phase III studies, which demonstrated efficacy at 5-weeks that children and adolescents (6-17 years) with ADHD treated with KAPVAY™ experienced statistically significant improvements in core symptoms of ADHD – inattention, hyperactivity and impulsivity. The most common and drug related adverse reactions (incident at least 5% and twice the rate of placebo) included somnolence, fatigue, upper respiratory tract infection (cough, rhinitis, sneezing), irritability throat pain (sore throat), insomnia, nightmares, emotional disorder, constipation, nasal congestion, increased body temperature, drug mouth and ear pain.  Maintenance efficacy has not been systemically evaluated and patients who are continued on longer-term treatment require periodic reassessment.

About KAPVAY™

Administered orally, clonidine hydrochloride exerts its pharmacological effects as a centrally acting alpha2-adrenoceptor agonist. The formulation in KAPVAY™ is designed to delay the absorption of active drug in order to decrease peak to trough plasma concentration differences.

Important Safety Information

KAPVAY™ should not be used in patients with known hypersensitivity to clonidine.

KAPVAY
'/>"/>

SOURCE Shionogi Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related biology technology :

1. Stallergenes and Shionogi Sign Exclusive Partnership Agreements for Immunotherapy Tablets in Japan
2. BioCrysts Partner Shionogi Receives Marketing & Manufacturing Approval For Peramivir in Japan
3. Orexigen® Therapeutics Announces Upcoming Data Presentations at the 28th Annual Scientific Meeting of The Obesity Society
4. Intra-Cellular Therapies Announces Positive Results with ITI-002 in Pre-Clinical Models of Parkinsons Disease
5. Bioheart, Inc. Announces Loan to be Assumed by Seaside
6. Shire Announces Results of the Tender Offer for Movetis NV and Commencement of Squeeze-Out Tender Period
7. IGEN AMENDS DISTRIBUTION AGREEMENT AND ANNOUNCES FIRST SPECTRUM BUILD-OUT
8. Crescendo Biologics Announces First Triple Knockout Mouse
9. Pepscan Therapeutics Announces Establishment of Scientific Advisory Board
10. Jiangbo Pharmaceuticals Announces Conference Call to Discuss Results for Fourth Quarter Fiscal 2010
11. Cellectis Bioresearch Announces Availability of Research Kits Through New Online E-Store
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/30/2014)... October 30, 2014 2014 Deep ... Industry” is a professional and in-depth research report ... basic Naltrexone HCL information, including its definition, classification, ... industry overview. This research covers the international market ... global industry analysis covering macroeconomic environment & economic ...
(Date:10/30/2014)... 2014 Rancho BioSciences , the ... manually curated public data source TCGA for ... the data is now available for other oncology groups. ... and internal data sources for their Pharma, Government and ... the data that becomes more easily accessible. Rancho ...
(Date:10/30/2014)... York, NY (PRWEB) October 30, 2014 ... plan for its ICH Stability Testing and Package Test ... this investment centers on a dramatic increase in environmental ... volume of stability, storage and aging samples to be ... stage of this major capital expenditure has already taken ...
(Date:10/30/2014)... Oct. 30, 2014 Isis Pharmaceuticals, Inc. (NASDAQ: ... that management will present a company overview at the Nomura ... ET in Boston, MA. ... the "Investors & Media" section of the Company,s website, ... website within 48 hours and will be archived for a ...
Breaking Biology Technology:Naltrexone HCL Market & Nalbuphine HCL Industry Analysis for Global, China Regions Now at DeepResearchReports.com 2Naltrexone HCL Market & Nalbuphine HCL Industry Analysis for Global, China Regions Now at DeepResearchReports.com 3Rancho BioSciences Manually Curated TCGA Data Sets Available 2Whitehouse Labs Announces Major Capital Investment in Stability and Storage Testing Capacity 2Whitehouse Labs Announces Major Capital Investment in Stability and Storage Testing Capacity 3Isis Pharmaceuticals to Present at the Nomura Biotechnology Conference 2
... Oct. 26, 2011 Accuray Incorporated (Nasdaq: ... announced today significant momentum in global adoption of its ... are now in use at leading cancer centers throughout ... image-guided, intensity-modulated radiation therapy (IG-IMRT) for routine radiation therapy ...
... poison from this smorgasbord of recent salmonella outbreaks in ... That,s in 2011 alone, and the list goes on, ... Prevention. But perhaps not for long, thanks to a ... of salmonella bacteria before contaminated food or animals reach ...
... ProteinSimple today announced the launch of the ... Imaging platforms. Bot1 automates analysis of protein aggregates and ... the IBC,s 11th Annual Formulation Strategy for Protein Therapeutics ... Protein therapeutic manufacturers must monitor microscopic particles and ...
Cached Biology Technology:Accuray Announces Rapid Clinical Adoption of TomoDirect™ Treatment Delivery Mode 2Accuray Announces Rapid Clinical Adoption of TomoDirect™ Treatment Delivery Mode 3Accuray Announces Rapid Clinical Adoption of TomoDirect™ Treatment Delivery Mode 4ProteinSimple Automates Aggregation Analysis 2
(Date:10/30/2014)... NY, October 30, 2014—Oligonucleotide-based therapeutics present unique challenges ... cause reproductive and developmental harm. New consensus guidelines ... combined chemical and biological characteristics of these novel ... , a peer-reviewed journal from Mary Ann ... free on the Nucleic Acid Therapeutics ...
(Date:10/30/2014)... | Heidelberg, 30 October 2014 Biological membranes are ... understanding of adsorption of solution ions onto lipid ... Now, a new study provides a quantitative description ... solution ions. Joanna Kotyńska and Zbigniew Figaszewski from ... of a study describing these findings, just published ...
(Date:10/29/2014)... their hair as a consequence of chemotherapy will benefit ... scalp cooling technology that prevents hair loss. , The ... by global scalp cooling manufacturing company, Paxman Coolers, of ... of the University of Huddersfield. , The research will ... a background in the pharmacology of cancer treatment, which ...
Breaking Biology News(10 mins):New guidelines for reproductive & developmental toxicity testing of oligonucleotide drugs 2Ion adsorption matter in biology 2New technology on the way to aid cancer suffers who lose their hair after chemotherapy 2
... Marine Board-ESF published its 13th Position Paper, which presents ... needed to assess the effects of anthropogenic sound upon ... Board Position Paper 13 results from the activities and ... marine mammals convened at the joint European Marine Board ...
... gorgeously-decorated fish which throng Australia,s coral reefs and help earn ... be written in their genes. Of particular importance may ... re-colonise regions of reef devastated by global warming and other ... says Dr Line Bay of the ARC Centre of Excellence ...
... base and,revenues, JERICHO, N.Y., Sept. 29 ... it has executed a non-binding,Letter of Intent with ... controlling interest in Biometric Solutions, Inc. The terms ... Biometric Solutions LLC is a premiere engineering firm, ...
Cached Biology News:Effects of anthropogenic sound on marine mammals -- a research strategy 2Fishy future written in the genes 2Fishy future written in the genes 3bioMETRX, Inc. Signs Deal To Acquire Controlling Interest in Biometric Solutions, LLC 2bioMETRX, Inc. Signs Deal To Acquire Controlling Interest in Biometric Solutions, LLC 3
Pronase Reagent...
CircuLex Anti-Human S100P Polyclonal Antibody Research Focus: proliferation Storage: -20C Shipping Temperature: 4C...
Rabbit polyclonal to ECSIT ( Abpromise for all tested applications). entrezGeneID: 51295 SwissProtID: Q96HQ7...
HAMP Immunogen: HAMP (AAH20612, 25 a.a. ~ 85 a.a) full length recombinant protein with GST tag. Storage: -20 C, Avoid Freeze/Thaw Cycles *Available for distribution in the US only...
Biology Products: