Drug maker Schering-Plough Corp. (SGP) on Friday said it has received approval of the U.S. Food and Drug Administration, or FDA, for Saphris, or asenapine sublingual tablets, for treatment of schizophrenia and bipolar disorder in adults.
The Kenilworth, New Jersey-based company, which is preparing to merge with Merck & Co., Inc. (MRK) by year-end, noted that Saphris could be used as a first-line treatment and is the first psychotropic drug to receive initial approval for both of these indications simultaneously.
Saphris is expected to be available in the U.S. during the fourth quarter of 2009. The new agent, according to the company, represents an important new choice for acute treatment of schizophrenia and acute manic or mixed episodes of bipolar I disorder with or without psychotic features in adults.
Schizophrenia affects about 24 million people worldwide, including two million Americans. Bipolar I disorder affects about 1% of adults, including 10 million Americans.
The FDA decision was reportedly based on a clinical study involving more than 3,000 patients with acute schizophrenia or bipolar mania, where patients were followed for up to two years.
Administration of antipsychotic drugs, including Saphris, has significant risks, the company noted. There are concerns about using the drug in patients with risk factors for diabetes mellitus. Saphris is not approved for the treatment of patients with dementia-related psychosis and is not recommended in patients with severe hepatic impairment.
The company said that the risk of developing Tardive Dyskinesia, a movement disorder, and the potential for it to become irreversible may increase as the duration of treatment and the total cumulative dose increase. The drug maker further said that in clinical trial and postmarketing experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents, including Saphris.
Commonly observed adverse reactions in patients with schizophrenia were akathisia, oral hypoesthesia and somnolence. In patients with bipolar disorder, common adverse reactions were found to be somnolence, dizziness, extrapyramidal symptoms other than akathisia and weight increase.
Last week Schering-Plough's shareholders voted to approve its proposed merger with Merck. The $41.1 billion stock and cash transaction is expected to close in the fourth quarter of 2009.
The company last month reported a rise in second-quarter profit, on lower costs, despite 6% decline in revenues. Schering-Plough's net income available to common shareholders increased to $633 million or $0.38 per share from $424 million or $0.26 per share in the previous year. Net sales for the quarter decreased to $4.65 billion from $4.92 billion in the year-ago quarter. Schering-Plough generates about 70% of its revenue from outside the U.S., including more than $2 billion in annual revenue from emerging markets.
SGP is currently trading at $26.88, down $0.23 or 0.85%, on 572,894 shares.
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