Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Pfizer Receives FDA Approval for Geodon® Capsules for the Adjunctive Maintenance Treatment of Bipolar Disorder in Adults

Published: Monday, November 23, 2009
Last Updated: Monday, November 23, 2009
Bookmark and Share
Data show Geodon used as an adjunct to Lithium or Valproate Is effective in the maintenance treatment of Bipolar I disorder.

Pfizer has announced that the U.S. Food and Drug Administration (FDA) has approved Geodon® (ziprasidone HCI) Capsules for maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults.

The approval is based on clinical data demonstrating that Geodon is an effective and generally well-tolerated adjunctive treatment for long-term symptom control in patients with bipolar disorder.

“The FDA approval of Geodon provides an additional treatment option for patients with bipolar disorder, who require maintenance therapy to keep the symptoms of the disease under control," said Charles Bowden, clinical professor of psychiatry and pharmacology, University of Texas Health Science Center.

The efficacy and safety of Geodon for the adjunctive maintenance treatment of bipolar disorder were studied in a six-month, double-blind, randomized, placebo-controlled trial in adult patients with bipolar I disorder. After an open-label stabilization period of 10 to 16 weeks, 240 patients were randomized to continue on Geodon plus lithium or valproate, or to have Geodon replaced by placebo. The primary endpoint in this study was time to recurrence of a mood episode requiring intervention.

The data demonstrated that Geodon plus lithium or valproate was superior to placebo plus lithium or valproate in increasing the time to recurrence of a mood episode. During six months of treatment, 19.7 percent of patients in the Geodon arm required intervention for a mood episode, compared with 32.4 percent of patients in the placebo arm.

The adjunctive Geodon treatment regimen was generally well-tolerated.4 Discontinuation due to adverse events occurred in 13 percent of patients in the placebo group, compared with 9 percent of those in the Geodon group.5 The safety and tolerability data from this study are consistent with Geodon’s already well-established safety profile in adult patients.

"The recurrence of mood episodes associated with bipolar disorder can have a devastating impact on patients’ lives,” said Dr. Ilise Lombardo, senior medical director, Pfizer Specialty Care. “This approval underscores Pfizer’s commitment to supporting people suffering from serious mental health disorders.”

Geodon is also FDA-approved for the treatment of acute manic and mixed episodes associated with bipolar disorder, with or without psychotic features, and for the treatment of schizophrenia. Since the FDA approval of Geodon in February 2001, nearly 2 million adult patients have been treated with this important therapy.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,300+ scientific posters on ePosters
  • More Than 4,900+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Pfizer to Acquire AstraZeneca Antibiotics
Pfizer has announced that it has entered an agreement with AstraZeneca to acquire its late-stage small molecule business for up to $1.575 billion.
Wednesday, August 24, 2016
Pfizer's $14Bn Acquisition of Medivation
It has been announced that Pfizer will acquire Medivation for $81.50 a share for a total value of roughly $14 billion.
Tuesday, August 23, 2016
Pfizer Acquires Bamboo Therapeurtics for $645M
Pfizer aims to become industry leader in gene therapy with aquisition of Bamboo Therapeutics.
Monday, August 01, 2016
Pfizer, Western Oncolytics Research Collaboration
Pfizer and Western Oncolytics have announced an immuno-oncology research collaboration.
Friday, July 29, 2016
Pfizer's $40M Bid for BIND Therapeutics
BIND Therapeutics announced Pfizer's $40 million winning bid at a Section 363 asset auction.
Thursday, July 28, 2016
Pfizer Advances Biosimilars Leadership with Investment in Biotechnology Center
Company has announced that the facility will foster the continued development of the biotechnology industry in China, further supporting National healthcare reforms.
Tuesday, June 28, 2016
Pfizer Breaks Ground On New Biologics Facility
The company has broken ground for its new biologics clinical manufacturing facility in Andover, Massachusetts.
Monday, June 20, 2016
Pfizer to Acquire Anacor
Company has entered into a merger agreement under which it will acquire Anacor for $99.25 per Anacor share in cash.
Thursday, May 19, 2016
Pfizer, IBM Collaboration Aims to Transform Parkinson’s Disease Care
Experimental “Internet of Things” system uses connected devices to enable remote measurement of health and quality of life in real-time.
Thursday, April 07, 2016
Pfizer Terminates $160bn Allergan Deal
Proposed merger agreement between Pfizer and Allergan has been terminated by mutual agreement of the companies.
Wednesday, April 06, 2016
Pfizer, Calibr Collaborate
The California Institute for Biomedical Research (Calibr), a nonprofit translational research institute, has announced that it has entered into a global strategic collaboration with Pfizer Inc. to develop novel antibody-based therapeutic agents for the treatment of heart failure.
Friday, January 15, 2016
Pfizer, Adaptive Biotechnologies Collaborate
Pfizer Inc. and Adaptive Biotechnologies Corporation have entered into a translational research collaboration to leverage next generation sequencing of the adaptive immune system to advance Pfizer’s growing immuno-oncology franchise.
Monday, January 11, 2016
Pfizer and Allergan to Combine
This move will create a new global biopharmaceutical leader with best-in-class innovative and established businesses
Tuesday, November 24, 2015
Pfizer and Synthon Enter into U.S. Commercialization Agreement
Synthon’s glatiramer acetate, a potential generic version of Copaxone®1 for the treatment of relapsing remitting multiple sclerosis is currently being reviewed by the U.S. Food and Drug Administration.
Friday, August 07, 2015
Pfizer Announces Expansion of Lease Agreement with MIT Subsidiary
Consolidation of Cambridge research centers creates a single Pfizer Cambridge campus to help expedite discovery and development efforts and encourage creative collaboration.
Friday, July 24, 2015
Scientific News
Shedding Light on HIV Vaccine Design
Broadly speaking - Mathematical modelling of host-pathogen coevolution sheds light on HIV vaccine design.
AACC 2016 Sees Clinical Chemistry Labs Drive Precision Medicine Offerings
Biomarker assays to enable precision medicine and risk assessment, mass spec-based tests designed for use in clinical labs large and small, and liquid biopsy technology captured the spotlight at the AACC annual meeting.
Automated Patch Clamping Trends
Learn more about current practices, preferences and metrics in ion channel drug screening using APC technology.
Lab-on-a-Stick: Miniaturised Clinical Testing For Fast Detection Of Antibiotic Resistance
A portable power-free test for the rapid detection of bacterial resistance to antibiotics has been developed by academics at Loughborough University and the University of Reading.
Genetic Ancestry of Cultivated Strawberry Unravelled
UNH scientists constructed a linkage map of the seven chromosomes of the diploid Fragaria iinumae, which allows them to fill in a piece of the genetic puzzle about the eight sets of chromosomes of the cultivated strawberry.
Progress In Vaccination Against Vespid Venom
Researchers at the Helmholtz Zentrum München and the Technical University Munich have presented a method which facilitates a personalised procedure for wasp allergy sufferers.
New Drug Target for Inflammatory Disorders
Penn study finds enigmatic molecules maintain equilibrium between fighting infection and inflammatory havoc.
Breast Cancer Cells Found To Switch Molecular Characteristics
Spontaneous interconversion between HER2-positive and HER2-negative states could contribute to progression, treatment resistance in breast cancer.
Mechanisms of Calcium Blockers
Researchers describe how the fundamental mode of action of two distinct chemical classes of calcium channel blockers differs.
Some Breast Cancer Patients With Low Genetic Risk Could Skip Chemotherapy
Genetic test can help predict survival and guide treatment options.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,300+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,900+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!