The US Food and Drug Administration has issued a green light for Schering-Plough’s antipsychotic Saphris as a first-line treatment for schizophrenia and manic or mixed episodes associated with bipolar I disorder, marking the first time a psychotropic drug has won approval for both these indications simultaneously.
Regulators gave clearance to the drug, which acts on specific serotonin and dopamine receptors in the brain, after a comprehensive clinical trials programme showed that the sublingual pill induced significant improvements in the symptoms of schizophrenia as well as a significant reduction in the symptoms of bipolar mania compared to placebo.
Both the company and its investors will undoubtedly be thrilled by the news, particular as the markets for these two conditions are enormous, with schizophrenia affecting about 24 million people worldwide and bipolar I disorder about 1% of all adults.
Doctors have also welcomed news of a new treatment option for these complex illnesses, which, according to schizophrenia study author Steven Potkin, professor at the department of psychiatry and human behaviour at University of California, “can present clinical challenges for the physician”.
And as Roger McIntyre, associate professor of psychiatry and pharmacology at the University of Toronto, Canada, and lead author of the pivotal bipolar mania studies with the drug, pointed out: “Having a new FDA-approved treatment such as Saphris (asenapine) is important in these serious conditions because physicians need options to help manage their patients’ symptoms”.
Competitive edge?
Analysts believe that Saphris, which was filed with European regulators under the brand name Sycrest in June, has the potential to do very well indeed particularly as it is associated with negligible weight gain and doesn’t seem to carry any cardiovascular safety issues, as some of the other atypical antipsychotics on the market do.
The company said it plans to make Saphris available throughout US pharmacies in the fourth quarter of this year.
