Navigation Links
US FDA approves ABILIFY for adolescent patients with schizophrenia
Date:11/6/2007

The findings are from a six-week, double-blind, randomized, placebo-controlled, multi-center study that evaluated the efficacy and safety of ABILIFY in pediatric patients, 13-17 years old, with a primary diagnosis of schizophrenia. (1) The study, sponsored by Otsuka Pharmaceutical Co., Ltd. and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc. (Princeton, N.J.), was conducted at 101 centers in 13 countries and enrolled 302 ethnically diverse pediatric patients. All patients were experiencing an acute episode of schizophrenia and required hospitalization at the time of enrollment. (1) After a minimum three-day wash-out period without any antipsychotic treatment, pediatric patients were randomly assigned to receive one of two fixed doses of ABILIFY [10 mg/day (n=100) or 30 mg/day (n=102)] or placebo (n=100). (1) ABILIFY was started at 2 mg/day and titrated to the target dose. (1)

The primary efficacy endpoint was the mean change from baseline to endpoint (Week 6) in a standard measure called the PANSS Total Score, (1) which can range from 30 (no symptoms) to 210 points (most severe symptoms). (2) Safety evaluations included incidence of adverse events, discontinuation rate due to adverse events and laboratory measures. (1)

Approximately 85 percent of patients completed the six-week study (84 percent of ABILIFY 10 mg, 82 percent of ABILIFY 30 mg and 90 percent of placebo-treated patients). (1) Both doses of ABILIFY demonstrated significant improvement when compared to placebo in mean change from baseline to endpoint (Week 6) in PANSS Total Score. (1)

In this study of pediatric patients with schizophrenia, common adverse events (greater than or equal to 5 percent and at least twice the rate of placebo) associated with ABILIFY were extrapyramidal disorder, somnolence and tremor. These common adverse reactions appeared to have a possible dose response relationship: extrapyramidal disorder (ABILIFY 10 m
'/>"/>

Contact: Debra Kaufmann
debra.kaufmann@otsuka.com
240-683-3568
Otsuka America Pharmaceutical, Inc.
Source:Eurekalert

Page: 1 2 3 4

Related medicine news :

1. FDA Approves First Anti-Psychotic for Kids
2. FDA Approves New Roche West Nile Virus Blood Screening Test
3. FDA Approves Osteoporosis Drug to Cut Breast Cancer Risk
4. FDA Approves LEVAQUIN(R) Short-Course Therapy for Treatment of Complicated Urinary Tract Infections and Acute Pyelonephritis
5. FDA Approves SOMA(R) (carisoprodol) 250 mg
6. FDA Approves Expanded Label for FluMist(R) to Include Children Two to Five Years of Age
7. FDA approves expanded label for FluMist (influenza virus vaccine live, intranasal) to include childr
8. FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment for Leading Form of Adult Leukemia
9. ABIH Approves Certification Credit for SSPC Training Courses
10. FDA Approves REALIZE(TM) Adjustable Gastric Band for Morbid Obesity
11. FDA Approves New Flu Vaccine
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/27/2014)... Neil Haley, the Total Tutor host of the Simply ... about the importance of capacity to grow a business. , ... and is now a 5 Star Ambassador, Vi Millionaire, and ... titled "The Playful and Powerful Warrior Within You!" and holds ... out for over 1000 days straight. He is also ...
(Date:8/27/2014)... York, NY (PRWEB) August 27, 2014 Overcoming ... failure, he finally found his niche. The Women’s Radio Network, ... Armstrong for his continued support and dedication to the WRNW1 ... be able to have such a positive atmosphere.” After KC ... on Sirius XM of the Howard Stern show, “Howard 100 ...
(Date:8/27/2014)... 2014 A recently published study ... of time in correcting coagulopathy to prevent permanent injury ... of anticoagulants and examines medical conditions alleged to be ... although anticoagulants have been approved by the FDA to ... are also known to affect the consistency of the ...
(Date:8/27/2014)... (PRWEB) August 27, 2014 The use ... quality of life and may eliminate the need for ... During a recent AllMed webinar, Dr. Zanhua Yi, board ... related to determining medical necessity of erythropoiesis-stimulating agents (ESAs) ... (CKD). , The U.S. Food and Drug Administration (FDA) ...
(Date:8/27/2014)... August 27, 2014 iHire was ... as the “Most Creative Workplace” in Frederick, a ... Places to Work Awards. , Held at the ... is a joint partnership between the Frederick County ... Development, Frederick County Business Development and Retention, and ...
Breaking Medicine News(10 mins):Health News:Vi Millioniare GJ Reynolds Discusses The Importance of Capacity to Grow a Business on the Simply G Radio Show, a Division of the Simply G Media Network 2Health News:Vi Millioniare GJ Reynolds Discusses The Importance of Capacity to Grow a Business on the Simply G Radio Show, a Division of the Simply G Media Network 3Health News:The Women's Radio Network, WRNW1, Signs KC Armstrong to a Multi-Million Dollar Contract 2Health News:Flood Law Group Comments on Recent AAICH Study 2Health News:AllMed Webinar Helps Health Plans Determine Medical Necessity Of ESAs In The Treatment Of Chronic Kidney Disease 2Health News:AllMed Webinar Helps Health Plans Determine Medical Necessity Of ESAs In The Treatment Of Chronic Kidney Disease 3Health News:iHire Named Most Creative Workplace in Frederick, MD 2
... March 3, 2008 The International AIDS Vaccine Initiative ... Fund, a new funding mechanism that will identify and ... AIDS vaccine research field. This initial project will apply ... the size of a small coin, which has the ...
... a new genetic risk factor for coeliac disease, have, ... implicated in causing the condition. The team, lead by ... and The London School of Medicine and Dentistry, have ... now know, four of these are also predisposing factors ...
... March 2 Therap Services announces the,release of version ... applications. Therap version 7.2 will feature,new forms such as ... module and the Emergency Medical/Behavior Intervention Strategies,(EMBIS) form in ... 7.2 include: -- Behavior Plan and Behavior Event ...
... Incontinence, dropped organs not just a function of age, study ... women in the United States have one or more pelvic ... disorders, says a Kaiser Permanente study. , Frequent urge to ... of such disorders. , The study of 4,000 women (80 ...
... Md. and ST. PAUL, Minn., Feb. 29 /PRNewswire-USNewswire/,-- ... Society &,Family Services, application for full Hague Accreditation ... This achievement of Hague,Accreditation demonstrates CHSFS, commitment to ... and abroad., The Hague Convention on Protection ...
... OAKLAND, Calif., Feb. 29 California,s,largest nonprofit hospital ... negotiations Thursday covering 15,000 hospital,workers across California., ... of negotiations underway and,continue their joint efforts to ... services across the state. In 2004, Catholic Healthcare,West ...
Cached Medicine News:Health News:IAVI and VaxDesign partner to develop a clinical trial in a test tube for AIDS vaccines 2Health News:Scientists uncover further steps leading to celiac disease 2Health News:Therap Services Announces Release 7.2 for the Developmental Disability Community 2Health News:Therap Services Announces Release 7.2 for the Developmental Disability Community 3Health News:Pelvic Floor Disorders Affect 1 in 3 Women 2Health News:Children's Home Society & Family Services Achieves Full Hague Accreditation 2Health News:Catholic Healthcare West and SEIU Begin Negotiations for 15,000 Hospital Workers 2
(Date:8/27/2014)...  Zimmer Holdings, Inc. (NYSE and SIX: ZMH), a ... be participating in the Morgan Stanley 2014 Global Healthcare ... York, New York , on Tuesday, September 9, ... Zimmer, will be presenting at 9:10 a.m. Eastern Time.  ... will join Mr. Dvorak for the Q&A session. ...
(Date:8/27/2014)... 2014 Asterias Biotherapeutics Inc. (OTCBB: ASTY) has ... (FDA) to initiate a Phase 1/2a clinical trial of ... cord injury.  The approved trial follows the successful completion ... and is designed to assess safety and activity of ... spinal cord injuries, the first targeted indication for AST-OPC1 ...
(Date:8/26/2014)... Malaysia , Aug. 27, 2014 ... health insurance are fuelling the demand for medical ... the rise of medical tourism, the inflow of ... increasing. The market will continue its steady ascent ... to age-related and non-communicable diseases, compelling significant investments ...
Breaking Medicine Technology:Asterias Biotherapeutics Receives U.S. FDA Clearance to Initiate Phase 1/2a Clinical Trial of AST-OPC1 in Patients with Cervical Complete Spinal Cord Injury 2Asterias Biotherapeutics Receives U.S. FDA Clearance to Initiate Phase 1/2a Clinical Trial of AST-OPC1 in Patients with Cervical Complete Spinal Cord Injury 3Asterias Biotherapeutics Receives U.S. FDA Clearance to Initiate Phase 1/2a Clinical Trial of AST-OPC1 in Patients with Cervical Complete Spinal Cord Injury 4Asterias Biotherapeutics Receives U.S. FDA Clearance to Initiate Phase 1/2a Clinical Trial of AST-OPC1 in Patients with Cervical Complete Spinal Cord Injury 5Frost & Sullivan: Change in Demographics and Surge in Domestic Manufacturing Drive Asia-Pacific Medical Devices Market 2Frost & Sullivan: Change in Demographics and Surge in Domestic Manufacturing Drive Asia-Pacific Medical Devices Market 3Frost & Sullivan: Change in Demographics and Surge in Domestic Manufacturing Drive Asia-Pacific Medical Devices Market 4
Inquire...
... implant is a combination of innovative design, ... makes TheraSeed® treatment an ideal choice for ... that every TheraSeed® implant order is backed ... required by clinicians who must meet the ...
... a combination of innovative design, consistently reliable ... I-125 implant an ideal choice for your ... every BrachySource I-125 implant order is backed ... required by clinicians who must meet the ...
The silicone Tractfinder provides excellent fluoroscopic visualization. Manipulation of the movable core guidewire flexes the tapered proximal tip for maximum control in negotiating a tortuous ureter...
Medicine Products: