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Merck's Saphris cleared for new uses

Merck has won US Food and Drug Administration approval of new indications for its atypical antipsychotic Saphris

Merck has won US Food and Drug Administration (FDA) approval of new indications for its atypical antipsychotic Saphris (asenapine).

The sublingual tablets may now be marketed for the treatment of schizophrenia in adults, as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, and as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.

Saphris won its initial US approval in mid-August of last year for the acute treatment of schizophrenia in adults and as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults.

Earlier this month, the drug, which Merck markets as Sycrest outside the US, won approval throughout the EU for treating moderate to severe manic episodes in adult patients with bipolar I disorder. However, European authorities declined to approve the drug as a treatment of schizophrenia.

Saphris was acquired in late-stage clinical development by Schering-Plough as part of the company's 2007 merger with Organon International. Merck and Schering-Plough merged last year.

Merck has not yet reported sales figures for the recently launched drug.

8th September 2010

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