A New Post Hoc Analysis Indicates asenapine has Effect on Both Manic and Depressive Symptoms in Bipolar I Disorder Patients Experiencing Mixed Episodes

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A New Post Hoc Analysis Indicates asenapine has Effect on Both Manic and Depressive Symptoms in Bipolar I Disorder Patients Experiencing Mixed Episodes

PR Newswire ECNP, VIENNA, October 15, 2012

ECNP, VIENNA, October 15, 2012 /PRNewswire/ --

Post hoc analyses presented at the 25th European College of Neuropsychopharmacology (ECNP) congress show asenapine achieves significant control of mixed episodes in bipolar I disorder compared to placebo.

- For media outside China, Japan, UK, USA only.

Lundbeck today announced results from post hoc analyses in bipolar I disorder patients experiencing mixed episodes, which found asenapine has a significant effect on both manic and depressive symptoms versus placebo. The analyses used pooled data from two identically designed 3-week, randomised, double-blind flexible dose, placebo- and olanzapine-controlled trials and a 9-week, double-blind olanzapine-controlled extension study.

"One of the most challenging treatment goals in bipolar I disorder is to address mixed episodes, where both manic and depressive symptoms are present," said Professor Jean-Michel Azorin, Professor of Psychiatry at the Mediterranean University School of Medicine. "Mixed episodes are experienced by more than 40% of patients and are considered a severe presentation of bipolar I disorder. Further investigation into the potential to manage both depressive and manic symptoms simultaneously with one treatment is warranted."

Asenapine is a tetracyclic antipsychotic therapy for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. The efficacy of asenapine was studied using two scales; for manic symptoms the Young Mania Rating Scale (YMRS) and the Montgomery- Åsberg Depression Rating Scale (MADRS) for depressive [1] symptoms.

The changes in YMRS score from baseline to week 3 were:

Significantly greater with asenapine (-15.0 ± 0.9) compared to placebo (-11.5 ± 1.2; p=0.015) The difference between olanzapine and placebo was not statistically significant (-13.3 ± 0.9; p=0.169)

Asenapine was also significantly superior to placebo in change from baseline in MADRS total score at week 3 (-8.2 ± 0.9 versus -4.5 ± 1.2, respectively; p=0.009). The difference between olanzapine and placebo was not statistically [2] significant (-6.5 ± 0.8; p=0.181).

The composite response of both manic and depressive measures (classified as ≥ 50% reduction in YMRS and MADRS scores) rate at week 3 was:

Significantly greater with asenapine (46.3%) than with placebo (24.4%; p=0.023) The difference between olanzapine and placebo was not statistically significant (37.5%; p=0.141)

The composite remission (YMRS ≤ 12 and MADRS ≤ 10) rate was significantly greater with asenapine (44.8%) than [2] placebo (24.4%; p=0.033) at week 3; the difference with olanzapine was not significant (35.2%; p=0.218).

[2] Bipolar disorder affects 30 million people worldwide including over four million people in Europe. It is the sixth leading [3] cause of disability worldwide. People with bipolar disorder are part of a medically-burdened population that often experience multiple complications. It is estimated that approximately two thirds of patients will suffer a mixed episode at [4] some point in their illness.

Editor notes About the post hoc analyses

The efficacy of asenapine in the treatment of mixed episodes was assessed using post hoc analyses on pooled data from two identically designed 3-week, randomised, double blind, flexible dose, placebo- and olanzapine-controlled trials [2] and a 9-week, double-blind olanzapine-controlled extension study.

In the intent-to-treat population, 295 patients has a DSM-IV-TR mixed episode (placebo: 66; olanzapine: 122; asenapine: 107) in the 3-weeks trials. Of these, 102 patients (olanzapine: 56; asenapine: 46) entered the 9-week [2] extension study.

These post hoc analyses were conducted on the pooled 3-week data of the subset of patients diagnosed with a mixed [2] episode according to DSM-IV-TR, and complemented by the data collected during the 9-week extension trial.

About bipolar I disorder

Bipolar disorder (also known as manic-depressive disorder) is a chronic, episodic illness so named because sufferers [5] alternate between two poles of extreme moods - mania and depression. Bipolar I disorder is characterised by mania (episodes of elevated moods, extreme irritability, decreased sleep and increased energy), depression (overwhelming [5] feelings of sadness, suicidal thoughts), or a combination of both.

About asenapine

Asenapine is a sublingual tablet indicated for the treatment of moderate to severe manic episodes of bipolar I disorder in adults. Approximately 4,500 subjects, including more than 3,150 patients in phase II/III studies (including trials in schizophrenia), have contributed to asenapine safety and tolerability data and the clinical trial programme for asenapine [6],[7],[8] has included nearly 1,300 patients with manic or mixed episodes of bipolar I disorder.

About Lundbeck

H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international pharmaceutical company highly committed to improving the quality of life for people suffering from brain disorders. For this purpose, Lundbeck is engaged in the research, development, production, marketing and sale of pharmaceuticals across the world. The company's products are targeted at disorders such as depression and anxiety, psychotic disorders, epilepsy and Huntington's, Alzheimer's and Parkinson's diseases.

Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark. Today Lundbeck employs approximately 6,000 people worldwide. Lundbeck is one of the world's leading pharmaceutical companies working with brain disorders. In 2011, the company's revenue was DKK 16.0 billion (approximately EUR 2.2 billion or USD 3.0 billion ). For more information, please visithttp://www.lundbeck.com/.

References

1. Azorin, et al. Remission of Manic and Depressive Symptoms with Asenapine in Patients with Mixed Episodes. Presented at the 25th European College of Neuropsychopharmacology (ECNP) Congress, Vienna, October 2012 , Poster 2.e.019

2. World Health Organization. Disease incidence, prevalence and disability. Available at: http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_part3.pdf. Accessed August 24, 2012 .

3. Kleinman, L et al. Costs of bipolar disorder. Pharmacoeconomics. 2003;21:601-622.

4. Mackin, P. & Young, A.H. (2005) Bipolar disorders. Core Psychiatry (eds P. Wright, J. Stern, M. Phelan). Edinburgh. Elsevier Saunders.

5. National Institute of Mental Health. Bipolar Disorder 2009. Available at: http://www.nimh.nih.gov/health/publications/bipolar-disorder/nimh-bipolar-adults.pdf. Accessed August 24, 2012 .

6. Asenapine Summary of Product Characteristics, 2012.

7. McIntyre, R et al. A 3-week, randomized, placebo-controlled trial of asenapine in the treatment of acute mania in bipolar mania and mixed states. Bipolar Disorders. 2009:11:673-686.

8. McIntyre, R et al. Treatment of Mania in Bipolar I Disorder: Placebo and Olanzapine Controlled trials of Asenapine. Congress of European College of Neuropsychopharmacology, October 13-17, 2007 , Vienna, Austria.