New Drug Update 2009-2010 - LAFP

processing assessments (trails B errors). Risperidone-treated patients exhibited improvement in speed of
processing (trails A, digit symbol substitution test, and verbal fluency), but worsening in the domain of
reasoning and problem solving (Wisconsin card sorting test percentage of perseverative errors and total
number correct)( Neuropsychopharmacol. 2006;31(suppl 1):S251 & Biol Psychiatry. 2007;61:241S).
Table 1. Efficacy Outcomes from a 6-Week Placebo- and Risperidone-
Controlled Study Changes From Baseline
Efficacy Measures Asenapine Risperidone Placebo
PANSS total score −15.9 (P < 0.005) −10.9 −5.3
CGI-S scores −0.74 (P < 0.01) −0.75 (P < 0.005) −0.28
PANSS positive subscale scores −5.5 (P = 0.01) −5.1 (P < 0.05) −2.5
PANSS negative subscale scores −3.2 (P = 0.01) −1.05 −0.6
PANSS general psychopathology subscale score −7.2 (P < 0.005) −4.8 −2.2
(Biol Psychiatry. 2007;61:241S)
Additional ongoing studies are assessing asenapine in comparison with olanzapine, haloperidol, and
placebo in the treatment of patients with an acute exacerbation of schizophrenia and in the long-term
therapy of patients with schizophrenia. Asenapine is also undergoing evaluation in the treatment of
psychosis in elderly patients.
CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS: The contraindications, warnings, and
precautions for asenapine are similar to the other atypical antipsychotic agents and include warnings
regarding the potential for orthostatic hypotension and syncopy, weight gain, hyperglycemia and diabetes
mellitus, increased mortality in dementia-related psychosis, suicide risk, neuroleptic malignant syndrome,
tardive dyskinesia, seizures, leucopenia, neutrapenia, and agranulocytosis, QT prolongation,
hyperprolactinemia, potential for cognitive motor impairment and dysphagia..
BLACK BOX WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA
RELATED PSYCHOSIS
Asenapine may be associated with less weight gain than olanzapine and risperidone; however, additional
study results are necessary to fully characterize its impact on blood glucose and weight gain.
ADVERSE REACTIONS: The most frequently observed adverse reactions with asenapine included
insomnia, somnolence, nausea, anxiety, and agitatio
Adverse Events reported in the Schizophrenia Trials
Placebo N= 378
Asenapine 5
mg twice daily
N= 274
Asenapine 10
mg twice daily
N= 208
All Asenapine§ 5
or 10 mg twice
daily N=572
System Organ Class /
Preferred Term
Gastrointestinal
disorders
Constipation 6% 7% 4% 5%
Dry mouth 1% 3% 1% 2%
Oral hypoesthesia 1% 6% 7% 5%
Salivary hypersecretion 0%