US FDA accepts NDA for S-P's asenapine

US drug major Schering-Plough says that the US Food and Drug Administration has accepted the filing for review of a New Drug Application for asenapine, its fast-dissolving, sublingual tablet. The firm is seeking marketing approval from the FDA for the treatment of schizophrenia and acute mania or mixed episodes associated with bipolar I disorder.

In accepting the NDA, the FDA indicated that asenapine will receive a standard review. The clinical trial program thus far has consisted of schizophrenia and bipolar mania studies involving nearly 3,000 patients, noted S-P, which acquired the drug through its takeover of Dutch firm Organon BioSciences on November 19 (Marketletters passim).

In a recent clinical trial, asenapine was shown to be effective and well-tolerated in patients with acute schizophrenia, according to a six-week study published in the November issue of the Journal of Clinical Psychiatry. 5mg of the drug given twice daily was significantly more effective than placebo in improving both positive and negative symptoms associated with schizophrenia, based on the Positive and Negative Syndrome Scale (Marketletter November 19).