Navigation Links
FDA Approves AstraZeneca's SEROQUEL XR(R) for the Treatment of Bipolar Depression and Bipolar Mania
Date:10/10/2008

supplemental new drug applications (sNDAs) to the FDA to seek approval for these indications. The bipolar depression submission was supported by a clinical study of treatment with SEROQUEL XR compared with placebo in 280 patients diagnosed with bipolar depression.(5,6) The primary endpoint was change from baseline in MADRS(*) (Montgomery-Asberg Depression Rating Scale) total score compared to placebo at week 8. In the study, SEROQUEL XR at 300 mg once-daily was significantly more effective than placebo. The mean change in MADRS total score from baseline to Week 8 was -17.4 for SEROQUEL XR compared with -11.9 for placebo (p<0.001). In the bipolar depression trial, the most common adverse events (AEs) (greater than or equal to 5% and at least twice placebo) associated with SEROQUEL XR compared with placebo were somnolence (combined adverse events terms somnolence and sedation) (52% vs. 13%), dry mouth (37% vs. 7%), increased appetite (12% vs. 6%), weight gain (7% vs. 1%), dyspepsia (7% vs. 1%), and fatigue (6% vs. 2%).(5)

The bipolar mania submission was based on a clinical study of treatment with SEROQUEL XR compared with placebo in 316 patients with bipolar mania or mixed episodes with or without psychotic features.(5,8) The primary endpoint was change from baseline in YMRS(**) (Young Mania Rating Scale) total score compared to placebo at week 3. The study showed that SEROQUEL XR at 400 mg to 800 mg (mean dose 604 mg) once-daily produced a significantly greater improvement in YMRS scores from baseline to endpoint compared with placebo (- 14.34 vs. -10.52; p<0.001). In the bipolar mania trial, the most common adverse events (AEs) (greater than or equal to 5% and at least twice placebo) associated with SEROQUEL XR compared with placebo were somnolence (combined adverse events terms somnolence and sedation) (50% vs. 12%), dry mouth (34% vs. 7%), dizziness (10% vs. 4%), constipation (10% vs. 3%), weight gain (7% vs. 1%), dysarthria (5% vs. 0%), and nasal congesti
'/>"/>

SOURCE AstraZeneca
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9

Related biology technology :

1. Brazilian National Biosafety Technical Committee Approves Monsanto Company Insect-Protected Corn Trait
2. FDA Approves RISPERDAL(R) to Treat Adolescents with Schizophrenia and Children and Adolescents with Bipolar Mania
3. FDA Approves ACAM2000(TM) Vaccine for Protection Against Smallpox
4. NJ Board of Pharmacy Approves Wedgewood Pharmacy Technician-Training Program
5. FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment for Leading Form of Adult Leukemia
6. FDA Approves New 300mg Loading Dose Tablet for PLAVIX(R) (clopidogrel bisulfate)
7. FDA Approves Administration of LEXIVA(R) with Lower Dose of Boosting Medication Ritonavir
8. FDA Approves DORIBAX(TM) for the Treatment of Complicated Intra-Abdominal and Complicated Urinary Tract Infections
9. FDA Approves IXEMPRA(TM) (ixabepilone), a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Breast Cancer
10. FDA Approves Genzymes Renvela(TM) for Dialysis Patients
11. FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic-Phase CML
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/22/2015)... Warren, NJ (PRWEB) May 22, 2015 ... a new white paper that explores the potential of ... industries. The white paper was developed to help life ... they can leverage data to gain critical business insights. ... generated large amounts of data driven by patient profiling, ...
(Date:5/21/2015)... May 21, 2015 Seventh Wave Laboratories, ... and efficacy of pharmaceutical products and medical devices, announced ... MO 63043, a 50,000 sq. ft. building more than ... enable strategic growth. Facility renovations will begin immediately and ... space will occur in September. , “We are ...
(Date:5/21/2015)... May 21, 2015  Prima Biomed Ltd. (NASDAQ: ... striving to become a leader in the development of ... that the final CVac data from the Phase II ... trend for a clinically meaningful improvement in Overall Survival ... patients. In the group of second remission ...
(Date:5/21/2015)... -- Imagine being able to probe and ... others. Being able to read faces and enjoy genuine ... anticipate their thoughts and actions like never before. Use ... create unique abstract paintings and video, or, play a ... first-person-shooter as it creates action, dialog, and outcomes based ...
Breaking Biology Technology:New White Paper Explores the Potential of Big Data Analytics in Life Sciences and Healthcare 2Seventh Wave Laboratories Purchases Building for Expansion, Upcoming Move 2Seventh Wave Laboratories Purchases Building for Expansion, Upcoming Move 3Correction Continues after Big Move - BrokerBank Securities, Inc. 25 Days to Meet ARGUS - The World's First Contactless Emotions Scanner 2
... ,Arpida Ltd (SWX: ARPN) presented a large body ... iclaprim at the 47th annual Interscience,Conference on Antimicrobial ... major scientific conference where thousands of scientists and,clinicians ... the latest,developments in the field of infectious diseases. ...
... in ... platelets, WORCESTER, Mass., Sept. ... bacterial contaminants in,blood cells and tissue, has received 510 (k) clearance for ... This provides,Verax authorization to market the device, which cuts the detection time ...
... In a sea of,streamers this morning, the most ... contribution to Florida Children,s Hospital from Walt Disney,World and ... banner,from the 11- story hospital, The Walt Disney Company ... and laid the foundation for,the "Children,s Hospital of the ...
Cached Biology Technology:Arpida Presents Preclinical and Clinical Data on Iclaprim at ICAAC 2Arpida Presents Preclinical and Clinical Data on Iclaprim at ICAAC 3Arpida Presents Preclinical and Clinical Data on Iclaprim at ICAAC 4Verax Biomedical Receives 510 (k) Clearance from FDA for Platelet PGD Test 2Verax Biomedical Receives 510 (k) Clearance from FDA for Platelet PGD Test 3Florida Children's Hospital and Disney Unite to Create Magical Pediatric Hospital 2Florida Children's Hospital and Disney Unite to Create Magical Pediatric Hospital 3Florida Children's Hospital and Disney Unite to Create Magical Pediatric Hospital 4
(Date:5/11/2015)... , May 11, 2015 Curemark LLC, a ... start of a new Phase III double blind, randomized, ... novel formulation, CM-AT, on all children ages 3-8 with ... FDA Phase III double blinded clinical trial for CM-AT ... levels of the digestive enzyme chymotrypsin. This new trial ...
(Date:5/5/2015)... Conn. , May 5, 2015, NXT-ID, Inc. ... authentication company focused on the growing mobile commerce market, reminds ... Company,s Chief Technology Officer, is presenting  at CARTES SECURE CONNEXIONS ... May 5-7, 2015. The three-day conference is ... David is speaking in is themed Global Fraud: Where ...
(Date:4/20/2015)... April 20, 2015 Huntington Memorial Hospital is ... implant a new miniaturized, wireless monitoring sensor to manage ... first and only FDA-approved heart failure monitoring device that ... used by physicians to manage heart failure. ... implanted in the pulmonary artery (PA) during a non-surgical ...
Breaking Biology News(10 mins):Curemark, LLC, Launches New Phase III Trial in Expanded Population of Children with Autism 2NXT-ID, Inc.'s CTO, David Tunnell, Presents at CARTES SECURE CONNEXIONS AMERICA 2015 Today in Washington DC. 2NXT-ID, Inc.'s CTO, David Tunnell, Presents at CARTES SECURE CONNEXIONS AMERICA 2015 Today in Washington DC. 3Huntington Memorial Hospital Becomes First in the San Gabriel Valley to Offer Patients a New Heart Failure Monitoring Solution 2Huntington Memorial Hospital Becomes First in the San Gabriel Valley to Offer Patients a New Heart Failure Monitoring Solution 3
... investigating the carbon sink capacity of northern terrestrial ... carbon uptake period (CUP) has on average decreased ... uptake of northern ecosystems is decreasing in response ... January 3rd, in the journal Nature. The carbon ...
... Jefferson University Hospital and Jeffersons Kimmel Cancer Center have ... effect high dose vitamin C has on non-Hodgkin lymphoma ... Medicine and Kimmel Cancer Center in conjunction with the ... of vitamin C can slow the progression of the ...
... BioScience includes a special section entitled Managing for ... in the section highlight different aspects of attempts ... ecosystem-based management of coastal marine areas. ... marine ecosystems provide has grown in recent years, ...
Cached Biology News:Jefferson scientists studying the effects of high-dose vitamin C on non-Hodgkin lymphoma patients 2Resilience concepts poised to aid management of coastal marine ecosystems 2
iNOS/NOS Type II Purified Anti-Mouse, Anti-Rat, Anti-Human clone Polyclonal, Isotype Rabbit Ig, 150 µg Consult technical datasheet for details....
... Bio-Plex suspension array system, 100-240 V, uses ... simultaneous quantitative analysis of up to 100 ... well. The suspension array is composed of ... of which may be conjugated with a ...
... The high-throughput fluidics (HTF) system, 100-240 ... Bio-Plex suspension array system that automates delivery ... fluid into the Bio-Plex array reader. The ... a nonpressurized bulk sheath container to constantly ...
Cell Culture Flask, 75 cm, nontreated polystyrene...
Biology Products: