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Saphris effective, safe for manic, mixed episodes of pediatric bipolar I disorder

Results from a randomized trial indicate Saphris was effective and well-tolerated among adolescents with bipolar I disorder and manic or mixed episodes.

“Several atypical antipsychotics (risperidone, aripiprazole, quetiapine, and olanzapine) have demonstrated efficacy in treating children and adolescents with acute manic or mixed episodes. In adults, the frequency at which patients are switched from initial therapy to a second or third therapy is high,” Robert L. Findling, MD, MBA, of Johns Hopkins University and the Kennedy Krieger Institute, Baltimore, and colleagues wrote. “Adolescents with bipolar I disorder often have multiple trials of different antipsychotics, possibly as a result of efficacy and/or tolerability issues in this heterogeneous population. Thus, additional data and pharmacologic options are needed.”

To evaluate Saphris (asenapine, Actavis) for pediatric manic or mixed episodes of bipolar I disorder, researchers randomly assigned 403 patients aged 10 to 17 years to placebo, 2.5 mg, 5 mg or 10 mg of asenapine twice daily. Study participants had diagnosed bipolar I disorder and were currently in manic or mixed episodes.

Compared with placebo, mean differences in Young Mania Rating Scale scores were –3.2 (P = .0008) for those taking 2.5 mg of asenapine, –5.3 (P < .001) for those taking 5 mg, and –6.2 (P < .001) for those taking 10 mg.

Somnolence, sedation, hypoesthesia oral, paresthesia oral and increased appetite were treatment-emergent adverse events with an incidence of 5% or higher.

Incidence of weight gain ranged from 8% to 12% among participants receiving asenapine, compared with 1.1% among those receiving placebo (P < .05).

Mean change from baseline in fasting insulin, lipid parameters and glucose was greater among participants receiving asenapine than those receiving placebo, according to researchers.

“Other treatment options are needed for pediatric patients with bipolar I disorder because patients respond differently to medical interventions. Asenapine is another treatment option for this patient population,” Findling and colleagues wrote. “Primary efficacy analysis determined all 3 doses of asenapine were superior to [placebo] in the reduction of mania, as measured by change from baseline in [Young Mania Rating Scale] total score at day 21. Key secondary efficacy analysis determined that all 3 doses of asenapine were superior to [placebo] in the reduction of the severity of illness as measured by the [Clinical Global Impression scale for use in Bipolar Illness] overall score at day 21. Statistically significant improvements in both [Young Mania Rating Scale] and [Clinical Global Impression scale for use in Bipolar Illness] scores were observed from day 4 and 7 onwards, respectively.” – by Amanda Oldt

Disclosure: The study was designed by Merck and Co., Inc., which had direct oversight or participation in every stage of the study. Findling reports receiving research support from, acting as a consultant to, and/or serving on a speaker’s bureau of Alcobra, Alexza Pharmaceuticals, the American Academy of Child and Adolescent Psychiatry, the American Physician Institute, American Psychiatric Press, Bracket, Bristol-Myers Squibb, CogCubed, Cognition Group, Coronado Biosciences, Dana Foundation, Eli Lilly and Co., Elsevier, Forest, GlaxoSmithKline, Guilford Press, Johns Hopkins University Press, Johnson and Johnson, Jubilant Clinsys, KemPharm, Lundbeck, Merck, the National Institutes of Health, Neurim, Novartis, Otsuka, Oxford University Press, Pfizer, Physicians Postgraduate Press, Purdue, Rhodes Pharmaceuticals, Roche, Sage, Shire, Sunovion, Supernus Pharmaceuticals, Transcept Pharmaceuticals, Validus, and WebMD. Please see the full study for a list of all authors’ relevant financial disclosures.