Ferrer Internacional — Adasuve EMA EPAR public assessment report (EMEA/H/C/002400, 2013)
Ferrer Internacional · 2013 · EMA EPAR public assessment report
Report summary
The EMA's assessment of Adasuve (loxapine) for rapid control of mild-to-moderate agitation in adult schizophrenia or bipolar disorder patients is detailed. The report covers regulatory aspects, product quality, manufacturing, and non-clinical pharmacology, including loxapine's receptor binding, cardiovascular/CNS effects, and reproductive toxicity. Clinical pharmacology, environmental risk, and pivotal trial designs are also discussed. Two Phase III trials (004-301, 004-302) demonstrated significant efficacy in reducing agitation (PEC and CGI-I scores) compared to placebo. Safety concerns include respiratory adverse events (bronchospasm), sedation, extrapyramidal symptoms, hypotension, and QT prolongation. Risk minimization measures and post-marketing surveillance are outlined. The CHMP recommended marketing authorization with specific conditions due to these safety concerns.
Key findings — cited to the page
| Study design | 2 dose, double-blind, double-dummy, active and placebo controlled, randomized, 3-period cross-over study | study 204-407 · p.85 |
| Final results due date | September 2015 | study 204-401 · p.85 |
| Final report of study results due date | March 2016 | study 204-401 · p.85 |
| Final results due date | May 2015 | study 204-403 · p.85 |
| Final report of study results due date | September 2015 | study 204-403 · p.85 |
| PEC score change at 2 hours | -8.0 | study 004-301 · p.87 |
| Marketing Authorisation application submission date | 26 October 2011 | Adasuve · Europe · p.8 |
| Eligibility to centralised procedure agreed by EMA/CHMP | 21 October 2010 | Adasuve · Europe · p.8 |
| Initial proposed indication | ADASUVE inhalation powder is indicated for the rapid control of agitation in adult patients with schizophrenia or bipolar disorder. | Adasuve · p.8 |
| Legal basis for application | Article 8.3 of Directive 2001/83/EC - complete and independent application. | · p.8 |
| Procedure start date | 16 November 2011 | · p.9 |
| CHMP positive opinion date | 13 December 2012 | Adasuve · p.9 |
Source: Ferrer Internacional ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →