Secuado (asenapine) transdermal system
Psychiatry· 387 cited findings· 1 source document
Company: HISAMITSU
What the regulatory reviews say
Secuado (asenapine) transdermal system is a New Drug Application (NDA 212268) approved for the treatment of schizophrenia in adults, with a PDUFA Goal Date of October 13, 2019. The proposed starting dose is 3.8 mg/24 hours, and the proposed maximum dose is 7.6 mg/24 hours.
Efficacy was evaluated in a 6-week, randomized, double-blind, placebo-controlled, fixed-dose, inpatient study involving 614 patients. Secuado demonstrated statistically significantly superior improvement compared to placebo in both PANSS total score change from baseline and CGI-S assessment scale change from baseline. The probability of maintaining at least 75% adhesion for the transdermal system was 0.96, with a 95% lower confidence limit of 0.89.
Safety studies included animal models. The NOAEL for maternal toxicity and embryo-fetal development of asenapine was 1.5 mg/kg/day. The ratio of maternal AUC0-24h for asenapine at NOAEL to human steady state AUC0-24h was 2.4 times. In rabbit fetuses, the incidence of external abnormalities was 17 fetuses at the highest dose (HD) compared to 2 fetuses in the control group.
Key figures — cited to the source page
| PANSS total score change from baseline | statistically significantly superior to placebo | HISAMITSU — Secuado FDA Review, p.15 |
| CGI-S assessment scale change from baseline | statistically significantly superior to placebo | HISAMITSU — Secuado FDA Review, p.15 |
| Probability of maintaining at least 75% adhesion | 0.96 | HISAMITSU — Secuado FDA Review, p.117 |
| 95% lower confidence limit for probability of maintaining at least 75% adhesion | 0.89 | HISAMITSU — Secuado FDA Review, p.117 |
| NOAEL for maternal toxicity and embryo-fetal development (asenapine) | 1.5 mg/kg/day | HISAMITSU — Secuado FDA Review, p.47 |
| Ratio of maternal AUC0-24h for asenapine at NOAEL to human steady state AUC0-24h | 2.4 times | HISAMITSU — Secuado FDA Review, p.47 |
| Proposed Indication | Schizophrenia in adults | HISAMITSU — Secuado FDA Review, p.2 |
| Recommendation on Regulatory Action | Approval | HISAMITSU — Secuado FDA Review, p.2 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.