Schering-Plough Corporation has announced that the U.S. Food and Drug Administration (FDA) recently accepted the filing for review of the New Drug Application (NDA) for asenapine, a fast-dissolving, sublingual tablet.
Schering-Plough is seeking marketing approval from the FDA for the treatment of schizophrenia and acute mania or mixed episodes associated with Bipolar I Disorder.
In accepting the NDA, the FDA indicated that asenapine will receive a standard review.
The clinical trial program thus far has consisted of schizophrenia and bipolar mania trials involving nearly 3,000 patients.
Schering-Plough acquired asenapine through its combination with Organon BioSciences on November 19, 2007.
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.
It affects approximately one to five percent of adults, including more than 10 million adults in the United States and more than four million people in Europe.
The condition can start early in childhood or later in life, the average age of onset is between 15 and 25 years old.
Bipolar Disorder is the sixth leading cause of disability in the world.
About half of the patients with Bipolar Disorder who recover in response to treatment experience recurrence two years later.
Schizophrenia is a chronic, disabling brain disorder characterized by hallucinations, delusions, and disordered thinking.
About 24 million people worldwide (or seven in every 1,000 adults in the population) have schizophrenia, including more than two million people in the U.S. and more than four million people in Europe.
People with schizophrenia may hear voices other people don't hear or may believe others are trying to harm them. As a result, they may become socially withdrawn, fearful, and agitated.
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