FDA Approves Asenapine for Schizophrenia

The FDA has approved asenapine (Secuado, Noven Pharmaceuticals) for the treatment of adult patients suffering from schizophrenia. 

Asenapine is an atypical antipsychotic drug, (dopamine receptor antagonist that may also antagonize norepinephrine and serotonin (5-HT) receptors, according to the CMS), administered via a once-daily transdermal system patch.

“As people living with schizophrenia cycle through treatments their therapeutic options narrow, leaving them and their caregivers looking for new treatment options,” said Leslie Citrome, MD, MPH, clinical professor of psychiatry and behavioral sciences, New York Medical College in a statement. “In addition to offering a new delivery option, transdermal patches can also provide caretakers and healthcare providers with a non-intrusive, visual confirmation that a treatment is being utilized.”

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The recent approval is based upon results of an international, phase 3, double-blind, placebo-controled study in which asenapine showed statistically significant improvement from baseline in the change of total Positive and Negative Syndrome Scale (PANSS) compared to placebo at week 6 (primary endpoint) and Clinical Gloval Impression-Severity Scores (secondary endpoint. 

Asenapine is contraindicated in patients with severe hepatic impairment and/or known hypersensitivity to asenapine or any of its excipients.

Warnings and precautions issued within asenapine’s prescribing information include cerebrovascular adverse reactions in elderly patients with dementia-related psychosis; neuroleptic malignant syndrome; tar dive dyskinesia; metabolic changes; orthostatic hypotension; leukopenia, neutropenia, and agranulocytosis; QT prolongation; seizures; and potential for cognitive and motor impairment, external heat, application site reactions. 

Adverse events reported with the use of asenapine include extrapyramidal disorder, application site reaction, and weight gain. 

Full Prescribing Information