Schering-Plough asenapine submission accepted by regulator

Schering-Plough has announced that its new drug application for asenapine as a treatment for schizophrenia and acute mania or mixed episodes associated with bipolar I disorder have been accepted by the US Food and Drug Administration (FDA).

In doing so, the FDA will give the compound a standard review.

The compound is a fast-dissolving sublingual tablet, with its clinical trial programme involving nearly 3,000 patients.

“Schering-Plough acquired asenapine through its combination with Organon BioSciences on November 19th 2007,” the company reports.

Earlier this month, Organon announced the results of a new clinical study showing the compound to be well-tolerated and effective in schizophrenia patients.

This data was presented at the annual congress of the European College of Neuropsychopharmacology and the annual meeting of the American Psychiatric Association, as well as being published in the Journal of Clinical Psychiatry.

In the trial, patients administered with 5 mg of asenapine twice-daily showed improvements in both the positive and negative symptoms of schizophrenia when compared to those receiving a placebo.

Schering-Plough completed the acquisition of Organon Biosciences from Akzo Nobel last week for a total sum of 11 billion euros (7.8 million pounds).