HISAMITSU — Secuado FDA Review (NDA212268, ORIG 1, 2019)
HISAMITSU · 2019 · FDA Review (openFDA)
Report summary
The FDA review of Hisamitsu's NDA 212268 for Secuado (asenapine) transdermal system for adult schizophrenia recommends approval. The transdermal system demonstrated comparable bioavailability to sublingual asenapine, with dose proportionality established. Efficacy was shown in a 6-week, placebo-controlled study, with statistically significant improvements in PANSS and CGI-S scores. Non-clinical toxicology studies, including repeated-dose, genetic, and reproductive studies, identified dose-related body weight changes, hematological effects, and application site reactions, with embryo-fetal toxicity observed at higher doses in rabbits. The safety profile is largely consistent with sublingual asenapine, though application site reactions were common (20%), mostly mild. The product offers a new once-daily alternative for patients.
Key findings — cited to the page
| Percentage of patients with no evidence of skin irritation | 55 % | · p.99 |
| Incidence of irregular estrous cycle in female rats at LD (fertility study) | 9/20 | · p.45 |
| Incidence of irregular estrous cycle in female rats at HD (fertility study) | 12/20 | · p.45 |
| Percentage of patients with minimal skin irritation | 30 % | · p.99 |
| Incidence of irregular estrous cycle in female rats at MD (fertility study) | 10/20 | · p.45 |
| Point estimate of probability of maintaining at least 75% adhesion (HP-3070 (b)(4) on Abdomen) | 0.90 | HP-3070 · p.120 |
| Point estimate of probability of maintaining at least 75% adhesion (HP-3070 (b)(4) on Hip) | 0.89 | HP-3070 · p.120 |
| Point estimate of probability of maintaining at least 75% adhesion (HP-3070 (b)(4) on Abdomen) | 1.00 | HP-3070 · p.120 |
| Point estimate of probability of maintaining at least 75% adhesion (HP-3070 (b)(4)) excluding upper chest | 1.00 | HP-3070 · p.121 |
| Point estimate of probability of maintaining at least 75% adhesion (HP-3070 (b)(4)) excluding upper chest | 0.92 | HP-3070 · p.121 |
| AUC0-24 at NOAEL for female rats (Study R-1147) | 99.4 Ҁњ҅Ѥ/mL | Study R-1147 · p.48 |
| Point estimate of probability of maintaining at least 75% adhesion (HP-3070 (b)(4) on Upper Arm) | 0.90 | HP-3070 · p.120 |
Source: HISAMITSU ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →