Schering-Plough gets US approval for Saphris

The US Food and Drug Administration has approved drug major Schering-Plough's Saphris (asenapine) sublingual tablets for acute treatment of schizophrenia in adults and acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults.
The drug can be used as a first-line treatment and is the first psychotropic drug to receive initial approval for both of these indications simultaneously, and is expected to be available in the US during the fourth quarter of 2009, says S-P, which is in the process of merging with fellow USA-based Merck & Co.
S-P estimates Saphris sales will top $1 billion annually, although Natixis Bleichroeder analyst Jon LeCroy estimates that the drug could achieve total turnover of $650 million a year in 2013. Antipsychotics topped US drug sales for the first time last year, producing $14.6 billion in revenue, according to IMS Health.
Schizophrenia affects about 24 million people worldwide, including two million Americans, and bipolar I disorder affects about 1% of adults, including 10 million Americans.
The drug is in a newer category of medicines called atypical antipsychotics that generally are much more expensive than older drugs and have been widely claimed to be more effective and safer.
According to an FDA statement, the efficacy of Saphris in treating schizophrenia was studied in three short-term placebo-controlled and active-drug controlled clinical trials. In two of the trials Saphris demonstrated superior efficacy compared to an inactive pill (placebo) in reducing the symptoms of schizophrenia.
The efficacy of Saphris in the treatment of bipolar disorder was studied in two short-term placebo-controlled and active-drug controlled clinical trials in which Saphris was shown to be superior to placebo in treating symptoms of bipolar disorder, the agency added.