Navigation Links
Organon's Asenapine Effective in a Phase III Study for the,Treatment of Bipolar I Disorder; Results Unveiled at 2007 APA,Meeting

SAN DIEGO, May 21, 2007 /PRNewswire/ -- Asenapine -- an investigational drug being developed by Organon, the human healthcare business unit of Akzo Nobel, for bipolar I disorder and schizophrenia -- was demonstrated to be more effective than placebo in treating acute manic and mixed episodes associated with bipolar I disorder, according to new Phase III results, from a study presented at the American Psychiatric Association's 2007 Annual Meeting.

In the three-week study, patients treated with either asenapine or olanzapine experienced significant improvements in acute mania symptoms, versus patients given placebo. Both asenapine and olanzapine demonstrated superiority versus placebo by the second day of treatment and maintained this benefit throughout the trial.

"The consequences of untreated mania in patients with bipolar disorder can be devastating to patients and their families. We need more effective and more tolerable treatments for these patients," said Robert Hirschfeld, M.D., Professor and Chair of the Department of Psychiatry and Behavioral Sciences at The University of Texas Medical Branch, Galveston. "The results of this trial suggest that asenapine is an attractive option for the acute treatment of mania because of its rapid onset of action and modest side effect profile."

Phase III Study Overview

The Phase III, double-blind, international trial conducted at 55 centers including 29 sites in the United States enrolled 488 patients with a manic (69%) or a mixed episode (31%) of bipolar I disorder and a baseline Young Mania Rating Scale (YMRS) score greater than or equal to 20 at entry. The YMRS is an 11-item scale used to evaluate manic symptoms; a score of at least 20 represents moderate-to-severe mania. Patients were randomly treated with asenapine (5-10 mg twice daily; average daily dose, 18.2 mg), olanzapine (5-20 mg once daily; average daily dose, 15.8 mg), or placebo for three weeks. Dosing was flexible. The primary efficacy endpoint was a reduction in YMRS total score at day 21. Safety measures included adverse events, weight gain and scores on measures of extrapyramidal symptoms (neurological symptoms such as involuntary movement, rigidity, and tremors often associated with antipsychotic medications).(i)

At day 2, both asenapine and olanzapine provided greater mean reductions in YMRS scores versus placebo (-3.0 and -3.4, respectively, vs. -1.5; p<0.008 for asenapine, p<0.001 for olanzapine). At the end of the trial (day 21), both active treatments continued to produce significant mean improvements in mania symptoms versus placebo (-10.8 and -12.6, respectively, vs. -5.5; both p<0.0001).(i)

The overall incidence of treatment-related adverse events was 60.8% in the asenapine group, 52.9% in the olanzapine group, and 36.2% in the placebo group. Most adverse events were mild to moderate. The most commonly reported AEs (>6%) with asenapine included sedation, dizziness, headache, somnolence, and fatigue. Olanzapine was most commonly associated with sedation, dry mouth, dizziness, headache, somnolence, and weight gain. The incidence of extrapyramidal symptoms reported as an adverse event was 7.2% in the asenapine group, 7.9% in the olanzapine group, and 2.9% in the placebo group.(i)

Asenapine was found to be effective and safe in the treatment of acute mania associated with bipolar I disorder in this study.

About Bipolar Disorder

Bipolar disorder, commonly referred to as manic-depressive disorder, is a chronic, episodic illness characterized by mania (episodes of elevated moods, extreme irritability, and increased energy), depression (overwhelming feelings of sadness, suicidal thoughts), or a combination of both. Approximately 5.7 million people in the United States ages 18 and older (2.6 percent of the population) have bipolar disorder. The estimated annual costs in the United States related to bip olar disorder exceed $8.5 billion.(ii)

About Organon

Organon creates, manufactures and markets innovative prescription medicines that improve the health and quality of human life. Through a combination of innovation and business partnerships, Organon seeks to leverage its position as a leading biopharmaceutical company in each of its core therapeutic fields: fertility, gynecology and selected areas of anesthesia. It has extensive expertise in neuroscience and a rich and focused R&D program. Research areas also include immunology and specific areas of oncology. Organon products are distributed in over 100 countries worldwide, of which more than 50 have an Organon subsidiary. Organon is the human healthcare business unit of Akzo Nobel.

Safe Harbor Statement *

This press release may contain statements which address such key issues as Akzo Nobel's growth strategy, future financial results, market positions, product development, pharmaceutical products in the pipeline, and product approvals. Such statements should be carefully considered, and it should be understood that many factors could cause forecasted and actual results to differ from these statements. These factors include, but are not limited to, price fluctuations, currency fluctuations, progress of drug development, clinical testing and regulatory approval, developments in raw material and personnel costs, pensions, physical and environmental risks, legal issues, and legislative, fiscal, and other regulatory measures. Stated competitive positions are based on management estimates supported by information provided by specialized external agencies. For a more comprehensive discussion of the risk factors affecting our business please see our Annual Report on Form 20-F filed with the United States Securities and Exchange Commission, a copy of which can be found on the company's corporate website The 200 6 Annual Report on Form 20-F will be available in the second quarter of 2007.

    * Pursuant to the U.S. Private Securities Litigation Reform Act 1995.

    (i)  Hirschfeld R, Panagides J, Alphs L, et al. Asenapine in Acute Mania:

         A Randomized, Double-blind, Placebo- and Olanzapine-controlled Trial

         (ARES 7501005)

    (ii) National Institute of Mental Health. Available online at:

CONTACT: Frances DeSena of Organon USA Inc., +1-973-325-5353,; or Monique Mols (FOR EUROPE), of N.V. Organon, +31(0)412-665440, ; or Christopher Loder of Ogilvy PRWorldwide, +1-212-880-5371, On-site, +1-908-247-1568,

Web site:

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


Related medicine technology :

1. Organons Sugammadex Demonstrated a 9-12 Times Faster Recovery in Phase III Pivotal Trial as Compared to Neostigmine
2. Organons Sugammadex Demonstrated a 9-12 Times Faster Recovery in Phase III Pivotal Trial Compared to Neostigmine
3. New Study Shows That Extending Prophylaxis With Clexane / Lovenox (enoxaparin Sodium Injection) to 5 Weeks is More Effective Than 10 Days for Reducing the Risk of Venous Thromboembolism (VTE) in Acutely ill Medical Patients With Reduced Mobility
4. Eurands Zentase Effective in Treating Exocrine Pancreatic Insufficiency, Studies Show
5. Cimzia Effective in Reducing Signs and Symptoms of Rheumatoid Arthritis
6. Gabapentin Shown Effective for Fibromyalgia Pain
7. ApoCells Cancer Predictive Index Helps Oncologists Select the Most Effective Targeted Drug Therapy
8. Roxro Pharma’s Novel Intranasal Pain Reliever Effective, Well Tolerated in Phase 3 Study
9. XYOTAX More Cost Effective With Fewer Side Effects Than Gemcitabine or Vinorelbine in Treating Non-Small Cell Lung Cancer
10. Soliris Effective in PNH Patients With History of Aplastic Anemia and Myelodysplastic Syndromes
11. Repeated Radioimmunotherapy With 131I-Labetuzumab Appears Safe and Effective in Colorectal Cancer with Liver Metastases
Post Your Comments:
(Date:10/9/2015)... 9, 2015  Hi-Tech Pharmaceuticals ("Hi-Tech"), a leading ... and iForce Nutrition ("iForce"), one of the fastest-growing Sports ... , today announced that they have entered ... agreed to acquire iForce. The transaction will enhance ... distribution through iForce,s strong distribution network. ...
(Date:10/9/2015)... 2015 Adheron Therapeutics, a privately held ... , United States , ... acquired by Roche.  Adheron Therapeutics has developed a ... a cell surface protein called Cadherin-11 in order ... inflammatory and autoimmune diseases such as rheumatoid arthritis ...
(Date:10/9/2015)... October 9, 2015 El ,JCA-Mauvernay Award 2015, ... y Junko Takita    --> ... los doctores Yutaka Kondo y ... Award 2015, se ha otorgado a los doctores ... ™ , una compañía biofarmacéutica global con sede enSuiza, presentará el ...
Breaking Medicine Technology:
... (Nasdaq: INSM ), a biopharmaceutical company, announced ... Agency (EMA) has issued a positive opinion on the ... for inhalation), Insmed,s Phase 3-ready compound for cystic fibrosis ... infections.  The PIP covers children from birth to 18 ...
... /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (Nasdaq: SVA ... announced today it submitted the application to commence clinical ... China,s State Food and Drug Administration (SFDA) on March ... research program in 2008. The vaccine targets infants under ...
Cached Medicine Technology:
(Date:10/10/2015)... ... October 10, 2015 , ... The sixth annual cost ... the growth of cybercrime costs for US companies. The New York Times broke down ... With averages showing increases hovering around 20% among the companies surveyed, it only proves ...
(Date:10/10/2015)... ... October 10, 2015 , ... Story Chaser ... It works by reading various classics and inspiring stories and as words drop down ... , The animations are extremely aesthetic and can be interacted with, making it a ...
(Date:10/10/2015)... ... ... Isabel Healthcare will participate in the Cerner Health Conference October 11-14, 2015 ... Institute of Medicine’s latest report “Improving Diagnosis in Healthcare”, Isabel Healthcare will be featuring ... and consumers to potentially reduce the chance of error. The report suggests that most ...
(Date:10/10/2015)... FLA. (PRWEB) , ... October 10, 2015 , ... In ... has been named the Best Place To Work in Jacksonville, amongst medium-sized companies with ... September 27th and was followed up with a celebratory gala on October 1st. ...
(Date:10/9/2015)... ... October 09, 2015 , ... The American ... Dean for Graduate Medical Education J. Michael Finley, DO, as the recipient of ... selected for his impact on graduate medical education opportunities for osteopathic residents, and ...
Breaking Medicine News(10 mins):
... flu outbreak in February in India, the poultry market saw a ... the government assured the people that all the necessary measures are ... the avian flu the sales of chicken and other birds saw ... deaths due to bird flu the sales dips drastically. Every time ...
... of cognitive behavior therapy (CBT) in overcoming depression can ... the University of Pittsburgh School of Medicine. In a ... Journal of Psychiatry, the official journal of the American ... the response to therapy could be a valuable tool ...
... who suffer from severe urinary infection are more likely ... had found a link between acute infections and heart ... infections and clotting in large veins, reported the online ... at the London School of Hygiene and Tropical Medicine ...
... new genes found with breast tumors can predict the outcomes ... the report appearing in he April 1 issue of Clinical ... women at risk for an early relapse of breast cancer. ... discovered as a potential marker of relapse in hormone-receptor positive ...
... from Sheffield University most women still believe one-night stands ... revealed that women of all ages believe that sex ... ,The women community despite achieving liberation still feels ... of desperation or drunkenness. The research which was followed ...
... are still left confused despite making in-depth analysis in ... psychiatric problem that affects the children. ... which is beyond the scientists' control, between 30 percent ... co-existing conditions, so-called comorbidities that make diagnosis and treatment ...
Cached Medicine News:
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: