Schering-Plough Corp's (SGP.N) experimental antipsychotic drug Saphris appears to be effective and as safe as other similar medications, U.S. Food and Drug Administration staff said in a memo released on Tuesday.
The drugmaker, which is expected to be acquired by Merck & Co Inc (MRK.N) later this year, is seeking FDA approval of the drug to treat adults with acute schizophrenia or bipolar disorder.
It has touted Saphris, or asenapine, as one of its five "star" products with the potential to earn more than $1 billion a year.
Although no final conclusion has been made, "we generally are in agreement that the sponsor has provided adequate support to suggest effectiveness for asenapine for the claimed indications," Dr. Thomas Laughren, director of the FDA's Division of Psychiatry Products, wrote in a June 24 memo.
Additionally, the drug's safety profile was "acceptable" and appears to be "qualitatively similar to that observed for other atypical antipsychotic drugs," he wrote.
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