ADASUVE(Loxapine)

Psychiatry· 210 cited findings· 1 source document

Company: Ferrer Internacional

What the regulatory reviews say

ADASUVE (Loxapine) is an inhalation powder indicated for the rapid control of agitation in adult patients with schizophrenia or bipolar disorder. The Marketing Authorisation application was submitted on 26 October 2011, following eligibility to the centralised procedure agreed by EMA/CHMP on 21 October 2010. The legal basis for the application was Article 8.3 of Directive 2001/83/EC.

Efficacy was assessed by the change in PEC score from baseline. At 2 hours after Dose 1, the change in PEC score was -8.0 compared to -5.8 for placebo (p=0.0004), and -8.7 compared to -5.8 for placebo (p<0.0001). At 10 minutes after Dose 1, the change in PEC score was -3.4 compared to -1.7 for placebo (p<0.0001). At 20 minutes, it was -6.1 compared to -2.9 for placebo (p<0001). At 30 minutes, it was -7.6 compared to -4.1 for placebo (p<0.0001). At 45 minutes, it was -8.7 compared to -4.8 for placebo (p<0.0001). At 1 hour, it was -9.2 compared to -5.2 for placebo (p<0.0001). The CGI-I score at 2 hours after Dose 1 was 2.3 compared to 2.8 for placebo (p=0.0015).

Safety data included 1653 subjects in the safety population, with 578 receiving placebo. Notable adverse events for Staccato Loxapine included somnolence (61.7%) compared to placebo (14.9%), dizziness (36.2%) compared to placebo (4.3%), and dysgeusia (19.1%).

Key figures — cited to the source page

Change in PEC score from baseline to 2 hours after Dose 1	-8.0 vs -5.8 placebo (p=0.0004)	Ferrer Internacional — Adasuve EMA EPAR public assessment re, p.42
Change in PEC score at 10 minutes after Dose 1	-3.4 vs -1.7 placebo (p<0.0001)	Ferrer Internacional — Adasuve EMA EPAR public assessment re, p.45
Change in PEC score at 30 minutes after Dose 1	-7.6 vs -4.1 placebo (p<0.0001)	Ferrer Internacional — Adasuve EMA EPAR public assessment re, p.45
CGI-I score at 2 hours after Dose 1	2.3 vs 2.8 placebo (p=0.0015)	Ferrer Internacional — Adasuve EMA EPAR public assessment re, p.44
Somnolence (Staccato Loxapine)	61.7 %	Ferrer Internacional — Adasuve EMA EPAR public assessment re, p.72
Dizziness (Staccato Loxapine)	36.2 %	Ferrer Internacional — Adasuve EMA EPAR public assessment re, p.72
Initial proposed indication	ADASUVE inhalation powder is indicated for the rapid control of agitation in adult patients with schizophrenia or bipolar disorder.	Ferrer Internacional — Adasuve EMA EPAR public assessment re, p.8
Marketing Authorisation application submission date	26 October 2011	Ferrer Internacional — Adasuve EMA EPAR public assessment re, p.8

Source documents

Ferrer Internacional — Adasuve EMA EPAR public assessment report (EMEA/H/C/002400, 2013) (2013)

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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.