Symbyax as a Treatment for Bipolar Disorder

Symbyax^TM Shown to Help Patients With Bipolar Depression

New data show that Symbyax^TM Associated With Suicidal Thinking in Patients With Bipolar Depression within the first week of treatment. Another study demonstrated that having an early onset of bipolar disorder tripled the likelihood that a patient might respond to Symbyax.

Symbyax is the first and only FDA-approved treatment for the depressive phase of bipolar disorder.

"These data provide hope to patients whose lives are disrupted by bipolar depression, a devastating and difficult condition to treat that often results in suicide or suicide attempts," said Terence A. Ketter, M.D., Associate Professor of Psychiatry & Behavioral Sciences, and Chief, Bipolar Disorders Clinic, Stanford University School of Medicine. "The rapid reduction of symptoms associated with suicidal ideation suggests the potential benefit of Symbyax among bipolar depressed patients, who are at high risk of taking their own lives."

Key Findings

An eight-week analysis of 688 people that compared Symbyax (n=73), olanzapine (n=299) and placebo (n=316) in the treatment of bipolar I depression showed:

• Suicidal ideation, as measured by the Montgomery-Asberg Depression Rating Scale item 10 (MADRS-10), was significantly reduced in bipolar depressed patients by the first week of Symbyax treatment compared to patients receiving placebo or olanzapine.
• Symbyax significantly improved the symptoms of apparent sadness, reported sadness, pessimistic thoughts, and inner tension — four MADRS items correlated to suicidal ideation — within one week compared to placebo

Predictors of Response Study

In addition, a statistical analysis performed on acute phase data from a double-blind, randomized clinical trial comparing Symbyax (n=86), olanzapine (n=370) and placebo (n=377) in patients with bipolar depression found:

• Having an early onset of bipolar disorder (prior to age 20) tripled the odds of response to Symbyax among patients with bipolar depression. Response was defined as a greater than 50 percent decrease in Montgomery-Asberg Depression Rating Scale (MADRS) total score
• Early onset was the only independent variable evaluated that was significant for predicting response to Symbyax among patients with bipolar depression

"Since bipolar disorder often emerges in late adolescence or early adulthood, the high rates of response among bipolar depressed patients who had early onset suggests that Symbyax may work well in this large, well-defined population," said Robert W. Baker, M.D., Associate Medical Director, USMD Neurosciences, Eli Lilly and Company.

About Bipolar Disorder

Bipolar disorder typically emerges in adolescence or young adulthood, and episodes continue intermittently throughout life, often disrupting work, school, family, and social life. Patients with the disease have a higher risk of committing suicide than those with other psychiatric or medical disorders,(1) and without effective treatment, bipolar disorder can lead to suicide in nearly 20 percent of cases.(2) The relative risk of suicide among patients with bipolar depression has been shown to be nearly 35 times greater than among patients in the manic phase of bipolar disorder.(3)

Bipolar disorder, also known as manic-depressive illness, affects an individual's mood, behavior, and thinking. Unlike many illnesses, symptoms may be quite different at various phases of the illness. Treatment is challenging because some therapies that are effective for one phase of the illness may be counterproductive for another. For example, antidepressant treatments can precipitate manic episodes.

Bipolar disorder is a complex mental illness characterized by debilitating mood swings ranging from episodes of deep depression (feelings of extreme guilt, sadness, anxiety and, at times, suicidal thoughts) to episodes of mania (abnormal euphoria, elation and irritability), interspersed with periods of normal mood. Patients with bipolar disorder spend more than three times longer in the depressive phase than in the manic phase of the disorder and take longer to recover from it.

More than 2.5 million Americans live with a diagnosis of bipolar disorder but recent research indicates the real number may be as high as 10 million. The results of untreated bipolar disorder can be catastrophic. According to the National Institute of Mental Health, nearly one in every five people with the illness commits suicide. The World Health Organization estimates that bipolar disorder is the sixth leading cause of disability in the world.