Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
Become a Member | Sign in
Home>News>This Article

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 3,500+ scientific posters on ePosters
  • More than 5,100+ 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 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 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, 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 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
Pfizer Enters into Agreement with GlaxoSmithKline
Agreement with GSK to acquire Nimenrix and Mencevax vaccines.
Thursday, June 25, 2015
Pfizer Acquires Minority Interest in AM-Pharma
Option to acquire company may be exercised based on Phase II trial results for recombinant human Alkaline Phosphatase.
Tuesday, May 12, 2015
Merck and Pfizer Finalize Agreement to Co-Promote XALKORI®
Co-promotion of XALKORI allows the alliance between Merck KGaA, Darmstadt, Germany, and Pfizer to establish a combined oncology sales organization in key markets for the program.
Thursday, April 09, 2015
Pfizer to Acquire Hospira for $17B
Companies have into a definitive merger agreement under which Pfizer will acquire Hospira for $90 a share in cash for a total enterprise value of approximately $17 billion.
Thursday, February 05, 2015
Pfizer Acquires Redvax
Acquisition provides Pfizer with a preclinical CMV vaccine candidate.
Thursday, January 08, 2015
Pfizer Expands Rare Disease Research with Establishment of Gene Therapy Platform
Signs collaboration with Spark Therapeutics to advance phase 1/2 Adeno-associated virus (AAV) vector program in hemophilia B.
Friday, December 12, 2014
Pfizer Confirms Interest in AstraZeneca
Pfizer submitted a preliminary, non-binding indication of interest to the board of directors of AZ in January 2014 regarding a possible merger transaction.
Monday, April 28, 2014
Pfizer Presents Phase 3 Safety And Immunogenicity Data On HIV Drug
Pfizer Inc. presented the results from a Phase 3 study demonstrating the immunogenicity, tolerability and safety of Prevnar 13® in adults infected with HIV.
Tuesday, March 05, 2013
Pfizer Announces Positive Results From Phase 3 Cancer Study
Study PROFILE 1007 evaluates XALKORI® (crizotinib) in previously treated patients with ALK-positive advanced non-small cell lung cancer.
Wednesday, June 27, 2012
Pfizer and Private Access Announce Plans to Develop Online Community to Accelerate Clinical Research
Privacy-enhanced search technology addresses privacy concerns to increase patient participation.
Monday, August 31, 2009
Scientific News
Salford Lung Study - The First Real World Clinical Trial
In this podcast, we learn about the Salford Lung Study and its potential to revolutionize the way we assess new drugs and treatments around the world.
NIH Contributes to Global Effort to Prevent and Manage Lung Diseases
The large scale trial will measure health benefits of clean cookstoves.
Anti-Inflammatory Drugs Could Help Treat Depression
Anti-inflammatory drugs could be used to treat some cases of depression, which further implicates our immune system in mental health disorders.
Questioning the Safety of Selenium to Combat Cancer
Research indicates the need for change in practice as selenium supplements cannot be recommended for preventing colorectal cancer.
Scientists at NIH and Emory Achieve Sustained SIV Remission in Monkeys
The finding suggest that the immune systems of these animals are controlling SIV replication in the absence of antiretroviral therapy.
Painting the Way to Tumour Imaging
Tumour paint used in emergency surgery to aid cell identification for surgeons.
Anti-Cancer Drug Uses Tumour mRNA to Identify Responders
Phase I study of novel anti-cancer drug uses tumour mRNA expression to identify patients who will respond to the drug.
Targeting Estrogen Receptor Improves Survival in Breast Cancer
Trial finds estrogen receptor degrader significantly increases progression-free survival in patients with advanced breast cancer.
Clinical Trial Finds Medicine Program Alters Blood Serum
Meditation, yoga and vegetarian diet linked to decline in plasma metabolites associated with inflammation and cardiovascular disease risk.
Alzheimer’s Linked Protein Can Be Removed From Brain Without Hindering Memory, Learning
Researchers at UTSW have found that the mice can maintain their learning and memory when virtually all ApoE is removed from the brain but kept present in the liver to filter cholesterol.
Scroll Up
Scroll Down

SELECTBIO Market Reports
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
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,100+ scientific videos