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Parkinson's disease

Neurology· 6 reviewed drugs· 3432 cited findings behind them

What the regulatory reviews cover

This library contains regulatory review documents for several drugs indicated for Parkinson's disease. Onerji is indicated for motor fluctuations in advanced Parkinson's disease not sufficiently controlled by oral anti-Parkinson medicinal products, showing a reduction in OFF time of 2.1 vs 1.4 (ND0612 vs placebo). Exelon Patch is indicated for mild to moderate dementia associated with Parkinson’s disease (PDD), with an ADAS-cog mean change from baseline (15 cm patch) of -0.2. Xadago is for adult patients with idiopathic Parkinson’s disease as add-on therapy to levodopa, demonstrating a difference vs placebo in daily ON time without troublesome dyskinesia of 0.96 (safinamide 100 mg/day). Inbrija is for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease, showing an LS mean difference in UPDRS-III score (CVT-301 84mg vs placebo) of -3.92. Ongentys showed a difference in change from baseline in absolute OFF-time vs placebo (OPC 50 mg, FAS) of -54.31.

It is important to note that these drugs were studied in different trials, and therefore the figures presented are not directly comparable in a head-to-head manner. Ingrezza, while present in the library, is indicated for tardive dyskinesia, with an incidence of parkinson-like adverse events (INGREZZA) of 3 %.

The drugs — one cited result each

Onerji

Mitsubishi Tanabe Pharma

Reduction in OFF time (ND0612 vs placebo): 2.1 vs 1.4

Tanabe — Onerji EMA EPAR public assessment report (EMEA/H/C/, p.21

Exelon Patch

Novartis AG

ADAS-cog mean change from baseline (15 cm patch): -0.2

SANDOZ — Exelon FDA Review (NDA/BLA 022083, 2016), p.36

Xadago

Zambon

Difference vs placebo in daily ON time without troublesome dyskinesia (safinamide 100 mg/day): 0.96

Zambon — Xadago EMA EPAR public assessment report (EMEA/H/C/, p.60

Ongentys

Bial

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

Inbrija

Merz Pharma

LS mean difference in UPDRS-III score (CVT-301 84mg vs placebo): -3.92

Merz — Inbrija EMA EPAR public assessment report (EMEA/H/C/0, p.47

Ingrezza

NEUROCRINE

Incidence of parkinson-like adverse events (INGREZZA): 3 %

NEUROCRINE — Ingrezza FDA Review (NDA/BLA 209241, 2022), p.11

Different drugs were studied in different trials — these figures are not head-to-head comparisons.

Explore the full evidence

Every finding behind these drugs — searchable, comparable and answerable in plain language — is in the Neurology research library →

Lists reflect the regulatory review documents in this library, not all therapies that exist. Educational reference only — not medical or investment advice.

Parkinson's disease — 6 Drugs, FDA & EMA Review Findings | BioPharmaPT Neurology