METHODS: FIVE CLINICAL TRIALS WERE CONDUCTED IN
BIPOLAR DISORDER MANIC OR MIXED STATES: two 3-week trials (n = 976) comparing
asenapine to placebo, a 9-week extension (n = 504), and a 40-week extension (n = 107). One trial was conducted comparing
asenapine to placebo (n = 326) as adjunctive
therapy for subjects with an incomplete response to
lithium or
valproate. All trials were conducted in the USA and internationally.
RESULTS:
Asenapine was found to be efficacious for manic and mixed states in
bipolar disorder compared with placebo control, and compares equally well to
olanzapine on efficacy measures after 3 weeks of treatment.
Asenapine was not found to be efficacious for depression symptoms. Common
asenapine side effects in the 40-week extension trial were sedation,
insomnia, and
dizziness, and 31% reported clinically significant
weight gain, compared with 55% reporting clinically significant
weight gain with
olanzapine. Additionally, 18% had clinically significant changes in fasting
blood glucose levels compared to 22% of those on
olanzapine. In terms of patient acceptability, one concern may be
sublingual administration requiring no liquids or food for 10 minutes after dosing and a twice-daily regimen. Suggestions about addressing barriers to adherence and acceptability are provided.
CONCLUSION:
Asenapine is a promising new medication in
bipolar disorder.
Asenapine in the long-term has a more favorable
weight gain profile compared to
olanzapine. No benefit was seen for depression symptoms, a major patient-reported concern. Some side effects do not remit after the short-term trials in at least 10% of patients.