The drug Latuda, which was approved in 2010 for treatment in U.S. patients with schizophrenia, has now gained approval by the Food and Drug Administration for the treatment of depressive episodes in patients with bipolar disorder. The drug will be used either by itself or in conjunction with other medications, such as lithium or valproate.
"These two approvals represent a significant milestone not only for Sunovion and DSP, but for the millions of Americans who are living with bipolar disorder and struggling to manage the symptoms of bipolar depression," said Masayo Tada, Representative Director, President and Chief Executive Officer of Dainippon Sumitomo Pharma Co., Ltd., in a press statement. "We look forward to building on the strong foundation started in the United States to bring LATUDA to other markets around the world. In addition, we are preparing for Phase 3 clinical trials for bipolar I disorder (bipolar depression) in Japan, an important market for us, where Phase 3 clinical trials for schizophrenia are already underway."
Latuda is an atypical antipsychotic, or second generation antipsychotic, that alleviates symptoms associated with schizophrenia, such as hallucinations and delusions, without the side effect of restlessness.
The approval of the drug for major episodes of depression related to bipolar disorder was supported by two clinical trials, PREVAIL 1 and 2. The endpoint of both studies was a reduction in depressive symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) six weeks after initiation of the treatment. Another measurement was a change in Clinical Global Impression-Bipolar Version-Severity of Illness (CGI-BP-S) scores at six weeks as well.
"Patients with bipolar disorder spend the majority of their symptomatic time in the depressed phase of the illness. This phase most commonly results in impaired function, a remarkable decrease in quality of life and may lead to increased risk for attempted suicide," said Joseph Calabrese, M.D., Professor of Psychiatry and Director of the Mood Disorders Program at University Hospitals Case Medical Center, Case Western Reserve University. "Unfortunately, there are very few treatments specifically approved to treat the symptoms of bipolar depression, which represents a very large unmet medical need for patients and their families."
Bipolar-related depression results in mood swings and affects around 10.4 million American adults. Bipolar disorder is typically characterized by one major episode of manic or mixed manic/depressive episode, and afflicted people usually have one major depressive episode as well. When symptoms arise, patients tend to have episodes of depression, rather than manic symptoms. When patients experience the depressive phase of the disease, they often have thoughts of worthlessness and death and attempt suicide. Other symptoms are insomnia, depressed mood, loss of interest or pleasure in activities, weight loss, and the inability to concentrate.
Bipolar disorder is the sixth leading cause of disability in the world and one of the top 10 causes of disability in the U.S.