SEROQUEL XR(TM) Receives Approval From FDA for Maintenance Treatment of Sch...(tenance treatment of schizophrenia was b...),Health

Date:11/16/2007

tenance treatment of schizophrenia was based on clinical trial results in which patients who had responded to SEROQUEL XR for the treatment of schizophrenia for 16 weeks (n=197) were randomized and either continued on SEROQUEL XR (n=94; 400-800 mg/day, flexibly dosed) or were switched to placebo (n=103). The primary endpoint was the time from randomization to psychiatric relapse (hospitalization for worsening schizophrenia, increase in PANSS* Total score Greater Than or Equal To 30%, Clinical Global Impression-Global Improvement [CGI-I]** score Greater Than or Equal To 6, or need for additional antipsychotic medication to treat psychosis).(3)

* Schizophrenic symptomatology is measured on 30-item Positive and

Negative Syndrome Scale (PANSS) scale. Each symptom was rated on a

severity scale from 1-7. PANSS positive (7 items), negative (7 items),

and general psychopathology (16 items) subscale scores were summarized

to give the PANSS total score.(8)

** The Clinical Global Impression (CGI) consists of 3 global scales or

items (Severity of Illness; Global Improvement; Efficacy Index). For

the primary endpoint of Study 004, item 2, the Global Improvement

scale, was used to evaluate patients. The Global Improvement scale

involves the physician rating total improvement whether or not, in the

physician's judgment, it is due entirely to drug treatment (1=very much

improved to 7=very much worse).(9)

The adverse reactions reported for SEROQUEL XR in the longer-term placebo- controlled schizophrenia trial were generally consistent with those reported in the short-term placebo-controlled schizophrenia trials. The most common (Greater Than or Equal To 5% of patients) treatment emergent adverse events for the SEROQUEL XR group versus placebo group in the randomized phase were insomnia (8.5% vs 17.5%) and headache (7.4% vs 4.9%).(3,6)

Launched in 1997, SEROQUEL has bee
'/>"/>

SOURCE AstraZeneca Copyright©2007 PR Newswire. All rights reserved

4 GOOD

Page: 1 2 3 4 5 6 7 8
Related medicine technology :

1. INVEGA(TM) Significantly Reduced Symptoms of Schizophrenia Compared to SEROQUEL(R) in Acutely Ill, Hospitalized Patients
2. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
3. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
4. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
5. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
6. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
7. CryoCor Receives FDA Approval for Right Atrial Flutter
8. Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
9. Dimericine(R) Receives FDA Fast Track Designation for Treatment Of Photosensitivity in XP Patients
10. Poniard Pharmaceuticals Receives FDA Fast Track Designation for Picoplatin for Treatment of Small Cell Lung Cancer
11. Kosan Receives Completed Special Protocol Assessment for TIME-1 Pivotal Phase 3 Trial of Tanespimycin in Multiple Myeloma