Ongentys

Neurology· 586 cited findings· 1 source document

Company: Bial

What the regulatory reviews say

Ongentys (opicapone) is indicated as an adjunct therapy to levodopa/DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations. Clinical trials investigated its efficacy in reducing 'OFF-time' in patients.

In efficacy studies, opicapone demonstrated a mean change in absolute OFF-time (FAS) ranging from -56.0 minutes to -116.8 minutes. When compared to placebo, opicapone 25 mg showed a difference in change from baseline in absolute OFF-time of -37.21, and opicapone 50 mg showed a difference of -54.31. The proportion of OFF-time responders was 62.4% for opicapone 25 mg, compared to 50.4% for placebo.

Safety findings included discontinuation due to adverse events (AEs) ranging from 4.3% (opicapone 50 mg) to 6.7% (opicapone 25 mg), compared to 6.6% for placebo. The No Observed Adverse Effect Level (NOAEL) in repeat-dose toxicity studies in mice, rats, and monkeys was 1000 mg/kg/day. The Marketing Authorisation application was submitted on 25 November 2014, and a positive opinion for Marketing Authorisation was issued on 28 April 2015.

Key figures — cited to the source page

Difference in change from baseline in absolute OFF-time vs placebo (OPC 25 mg, FAS)	-37.21	Bial Portela C S A — Ongentys EMA EPAR public assessment rep, p.85
Difference in change from baseline in absolute OFF-time vs placebo (OPC 50 mg, FAS)	-54.31	Bial Portela C S A — Ongentys EMA EPAR public assessment rep, p.85
Proportion of OFF-time responders (OPC 25 mg)	62.4	Bial Portela C S A — Ongentys EMA EPAR public assessment rep, p.88
Discontinuation due to AEs for opicapone 50 mg	4.3	Bial Portela C S A — Ongentys EMA EPAR public assessment rep, p.54
Discontinuation due to AEs for opicapone 25 mg	6.7	Bial Portela C S A — Ongentys EMA EPAR public assessment rep, p.54
NOAEL in mice, rats and monkeys (repeat-dose toxicity)	1000	Bial Portela C S A — Ongentys EMA EPAR public assessment rep, p.19
Marketing Authorisation application submission date	25 November 2014	Bial Portela C S A — Ongentys EMA EPAR public assessment rep, p.5
Positive opinion for Marketing Authorisation date	28 April 2015	Bial Portela C S A — Ongentys EMA EPAR public assessment rep, p.7

Source documents

Bial Portela C S A — Ongentys EMA EPAR public assessment report (EMEA/H/C/002790, 2016) (2016)

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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.