Long‐term safety and efficacy of sublingual asenapine for the treatment of schizophrenia: A phase III extension study with follow‐up for 52 weeks (P06125)—Secondary publication

Abstract

After completion of a 6‐week double‐blind trial of asenapine sublingual tablets (10 or 20 mg/day) versus placebo in Asian patients with acute exacerbation of schizophrenia, including Japanese patients, this open‐label study evaluated the safety and efficacy of a 52‐week treatment with asenapine at flexible doses. In 201 subjects, including 44 who had received placebo (P/A group) and 157 who had received asenapine (A/A group) in the feeder trial, adverse events occurred at rates of 90.9% and 85.4% and serious adverse events at rates of 11.4% and 20.4%, respectively. One patient in the P/A group died. No clinically significant abnormal measurements of body weight, body mass index, or glycated hemoglobin, fasting plasma glucose, insulin, and prolactin levels were observed. The sustained efficacy rate, as evaluated by the Positive and Negative Syndrome Scale total score and other measures, remained at approximately 50% between 6 and 12 months of treatment. These results suggest that long‐term treatment with asenapine is well tolerated and provides sustained efficacy.

Effect of single-administration of d-sorbitol pretreatment on the bitterness and continued willingness to take asenapine: a randomized, single-blind, placebo-controlled, crossover trial

“…The results of this study showed that 40% of patients had not become accustomed to the taste of asenapine, even though they had taken it for a median duration of 3.7 years. Although the relationship between the side effects of asenapine and the reason for not being accustomed to the taste remains uncertain, our findings showed values that exceeded the previously reported rates of oral-related adverse effects [ 12 , 29 ]. This discrepancy might be explained by the fact that the patients in this study may have been more comfortable reporting asenapine-related adverse events through questionnaires than during a medical examination.…”

“…Another study reported that Asians are far more sensitive to bitter tastes than individuals of African-American, white, or Hispanic ethnic origin [ 32 ]. Furthermore, clinical data have also shown a higher incidence of oral hypoesthesia reported in Asian populations (about 10%) than in Western populations (about 5%) [ 10 , 11 , 14 , 29 ]. Therefore, clinicians should pay more attention to how patients feel about taking medicines and their side effects and consider discussing these issues with their patients and providing interventions to improve medication continuation.…”

Predictors of continuation for asenapine from real-world data in patients with schizophrenia

“…Interestingly, in the study, 71.3% of patients had a disease duration of at least 20 years, and 68.0% of patients received antipsychotics at a CP equivalent dose of ≥ 600 mg/day 19) . However, in the aforementioned P06125 study 17) , the percentage of patients whose duration of disease was 20 years or longer was 25.9%. No medication was administered before the start of the treatment with asenapine because a washout period was conducted according to the study design.…”

“…In a phase III study of asenapine (P06238 study) conducted in patients with residual schizophrenia, polypharmacy, overdose, treatment-resistance, or elderly schizophrenia, the 52-week continuation rate was 50.3%, which was the highest value so far reported 19) . Interestingly, in the study, 71.3% of patients had a disease duration of at least 20 years, and 68.0% of patients received antipsychotics at a CP equivalent dose of ≥ 600 mg/day 19) . However, in the aforementioned P06125 study 17) , the percentage of patients whose duration of disease was 20 years or longer was 25.9%.…”

“…In 2010, the 52-week asenapine continuation rate was reported as 38.0% 16) . In a 52-week long-term administration study (P06125 study) conducted as an extension study of a placebo-controlled study of asenapine, the continuation rate was reported as 42.8% 17) . In contrast, a retrospective study reported it to be 19.0% 18) .…”