Schering-Plough is going to have to wait a bit longer before it launches the schizophrenia drug asenapine in the USA as regulators are asking for more information.

The company has received a complete response letter from the US Food and Drug Administration about asenapine, which will be sold as Saphris, a sublingual tablet for the acute treatment of both schizophrenia and manic or mixed episodes associated with bipolar I disorder in adults. The letter includes proposed labelling for both indications and a request for supplemental data from the existing asenapine database.

However S-P stressed that no additional clinical trials have been requested and expects to provide the required information to the agency in the first quarter. The clinical trial programme originally lodged with the FDA in November 2007 involved more than 3,000 patients.

Thomas Koestler, president of the Schering-Plough Research Institute, said that “we are pleased with the progress on the Saphris filing and look forward to working with the agency to address its request, finalise the product labelling and gain approval". He added that “new treatments are needed in this therapeutic area and we believe that Saphris has the potential to be an important option”.

S-P got hold of Saphris through its acquisition of Organon BioSciences over a year ago.