Findings from a 52-week clinical study of Schering-Plough‘s Saphris (asenapine) have shown that the treatment significantly increases the time between relapses for patients suffering from schizophrenia.
During the double-blind phase of the study, time to relapse or impending relapse, the primary efficacy endpoint, was shown to be significantly longer with Saphris compared to placebo.
University of California professor, department of psychiatry and human behaviour Steven Potkin said that for patients with schizophrenia, symptoms return in more than half of all patients by two years and in more than 80% by five years.
“It is important that clinicians have new treatment options that not only effectively manage the symptoms of schizophrenia and are well tolerated by patients, but that also can help delay relapse,” Potkin said.
Saphiris was approved by the US Food and Drug Administration in August 2009 for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
The European Medicines Agency is validating a Marketing Authorization Application for asenapine, under the brand name Sycrest.