FDA Committee backs Schering-Plough's Saphris

The US Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee has voted unanimously in favor of drug major Schering-Plough's Saphris asenapine) sublingual tablets as effective and safe for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults and in favor of use in acute treatment of schizophrenia in adults. If approved by the FDA, Saphris would be the first psychotropic drug to be approved initially for both of these indications, the company notes.

Thomas Koestler, executive vice president and president, Schering-Plough Research Institute., commented: "in clinical studies, Saphris has demonstrated efficacy combined with an attractive metabolic safety profile. Saphris has the potential to address a significant unmet need for patients with schizophrenia and bipolar I disorder, including patients starting treatment and those who need alternative treatment options when switching or re-initiating therapy. We will continue to work with FDA to bring Saphris to the US market as soon as possible so that patients can benefit from this new medication."

After reviewing the Saphris data, the committee voted in favor of the drug as effective (by counts of 12/0/0 and 10/2/0, yes/no/abstain) and safe (12/0/0 and 10/0/2) for the bipolar I disorder and schizophrenia indications, respectively. In addition, the committee voted on the overall balance of safety and efficacy by counts of 12/0/0 and 9/1/2 for the bipolar I disorder and schizophrenia indications, respectively, according to S-P.