FDA Okays Saphris for Pediatric Bipolar Disorder

Caroline Cassels


March 13, 2015

The US Food and Drug Administration (FDA) has approved another atypical antipsychotic for the treatment of pediatric patients with bipolar I disorder.

According to a release issued by the drug's manufacturer, Actavis, asenapine (Saphris) received approval as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients aged 10 to 17 years.

The company notes that the drug is the only atypical antipsychotic treatment that offers a sublingual formulation.

According to the company, the FDA approval is based on the results of a 3-week monotherapy trial in 403 pediatric patients (aged 10 to 17 years), of whom 302 patients received Saphris twice daily in doses of either 2.5 mg, 5 mg, or 10 mg.

Saphris was shown to demonstrate improvement in Young Mania Rating Scale total score and Clinical Global Impression–Bipolar Severity of Illness overall score vs placebo.

The most common side effects of the drug observed in the trial were sleepiness, dizziness, strange sense of taste, numbing of the mouth, nausea, increased appetite, feeling tired, and weight gain.

Saphris will be available for pediatric patients with bipolar I disorder in 2.5-mg, 5-mg, and 10-mg black cherry–flavored sublingual tablets in the second quarter of 2015.

"Bipolar I disorder in children and teens is a significant public health problem in the US. The diagnosis and recognition of bipolar I disorder in children and teens continues to rise, and this illness can often be more severe in pediatric patients than adults," said study investigator Kiki Chang, MD, professor of psychiatry and behavioral sciences, Stanford University School of Medicine, in California. "The FDA approval of this pediatric indication for Saphris is very important because it provides an additional treatment option for children and teens affected by this complex condition."

The second-generation antipsychotic was first approved in 2009. It is indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy or as adjunctive therapy with either lithium or valproate, and for the acute and maintenance treatment of schizophrenia in adults.


The drug's risks include death, transient ischemic attacks, and stroke in elderly patients with dementia-related psychosis, and so it is not recommended for use in this patient population.

Other risks include severe liver impairment, serious allergic reaction, neuroleptic malignant syndrome, tardive dyskinesia, and metabolic changes that can increase cardiovascular risk, including hyperglycemia, dyslipidemia, and weight gain.

A link to the full prescribing information, including a boxed warning, can be found on the company's website.


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