FDA Approves Sublingual Asenapine for Expanded Use in Schizophrenia, Bipolar Disorder

September 14, 2010 — Merck has announced that its antipsychotic asenapine (Saphris), in sublingual dissolving tablet form, has been approved for expanded use by the US Food and Drug Administration (FDA).

The drug was first approved in the United States in August 2009 for the acute treatment of adult patients with schizophrenia and as monotherapy for acute mania or mixed episodes associated with bipolar 1 disorder.

The FDA has now given approval for its use as ongoing maintenance treatment for schizophrenia and as adjunctive therapy with lithium or with valproate for bipolar 1 disorder, according to a release from Merck.

However, the FDA has also issued a black box warning that this drug should not be used by elderly patients with dementia-related psychosis, based on a meta-analysis of 17 antipsychotics vs placebo trials. The results showed that those in this patient population treated with an antipsychotic had a risk of death that was almost 2-fold higher than those treated with placebo. The most common cause of death was found to be related either to cardiovascular or to infectious causes.

The most commonly observed adverse reactions (AEs) after asenapine treatment for schizophrenia have been akathisia, oral hypoesthesia, and somnolence.

Common AEs after bipolar monotherapy have included somnolence, dizziness, extrapyramidal symptoms other than akathisia, and weight gain. For bipolar adjunctive therapy, the AEs found were somnolence and oral hypoesthesia.

Other warnings cited included neuroleptic malignant syndrome, tardive dyskinesia, hyperglycemia and diabetes mellitus, orthostatic hypotension and syncope, leukopenia/neutropenia, QT prolongation, seizures, and the possibility for cognitive and motor impairment or suicide attempts.

Asenapine sublingual tablets are available in 5- and 10-mg doses.

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