Schering-Plough receives FDA approval for SAPHRIS

Schering-Plough has received approval from the Food and Drug Administration (FDA) for its SAPHRIS (asenapine) drug for the management of schizophrenia, the company has announced.

The organisation noted that the therapy has been granted authorisation for the acute treatment of the condition in adults, as well as for manic or mixed episodes that are associated with bipolar I disorder or have no psychotic features.

Professor Steven Potkin, head author of a pivotal schizophrenia trial that was undertaken as part of the SAPHRIS clinical development programme, said that bipolar I disorder and schizophrenia are both “complex” medical conditions.

He noted that they can present “clinical challenges” to physicians.

“Having a new FDA-approved treatment such as SAPHRIS is important in these serious conditions because physicians need options to help manage their patients’ symptoms,” added Roger McIntyre, associate professor of psychiatry and pharmacology at the University of Toronto.

Earlier this month, Schering-Plough announced the launch of CLARITIN Eye antihistamine drops.