Schering Plough - Saphris: approved by FDA with no comparative data

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 FDA approval of SAPHRIS is based on a New Drug Application (NDA) that included efficacy data from a clinical study program involving more than 3,000 patients in schizophrenia and bipolar mania trials. The SAPHRIS filing was supported by safety data in 4,500 people, with some patients treated for more than two years. The approval is based on acute schizophrenia trials in which SAPHRIS (5 mg twice daily) demonstrated statistically significant efficacy versus placebo and acute bipolar I disorder studies in which SAPHRIS (10 mg twice daily) demonstrated statistically significant reduction of bipolar mania symptoms versus placebo.

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