Inbrija
Neurology· 386 cited findings· 1 source document
Company: Merz Pharma
What the regulatory reviews say
Inbrija is an inhalation powder, hard capsule containing 33 mg strength of levodopa, indicated for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease (PD) who are already receiving levodopa/dopa-decarboxylase inhibitor therapy. The marketing authorization application was submitted on 23 March 2018, and a positive opinion for marketing authorization was issued on 25 July 2019.
Key efficacy findings from a Phase 3 trial at Week 12 showed a change in UPDRS-III score from predose to 30 minutes postdose of -9.83. The LS mean difference in UPDRS-III score for CVT-301 84mg versus placebo was -3.92. The percentage of ON responders within 60 minutes at Week 12 was 57.7%, compared to 36.1% for placebo. The median time to onset of meaningful ON was 29 minutes, while for placebo it was 32.4 minutes. The median duration of ON was 110 minutes, compared to 69 minutes for placebo.
Regarding safety, the proportion of patients experiencing dyskinesia ranged from 17.4% to 37.5% across different observations. The Tmax in humans after inhalation was 30 minutes.
Key figures — cited to the source page
| 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 |
| Percentage of ON responders within 60 minutes at Week 12 | 57.7 | Merz — Inbrija EMA EPAR public assessment report (EMEA/H/C/0, p.48 |
| Percentage of ON responders within 60 minutes at Week 12 (placebo) | 36.1 | Merz — Inbrija EMA EPAR public assessment report (EMEA/H/C/0, p.48 |
| Median time to onset of meaningful ON | 29 | Merz — Inbrija EMA EPAR public assessment report (EMEA/H/C/0, p.37 |
| Median time to onset of meaningful ON (placebo) | 32.4 | Merz — Inbrija EMA EPAR public assessment report (EMEA/H/C/0, p.37 |
| Median duration of ON | 110 | Merz — Inbrija EMA EPAR public assessment report (EMEA/H/C/0, p.37 |
| Proportion of patients with dyskinesia | 37.5 | Merz — Inbrija EMA EPAR public assessment report (EMEA/H/C/0, p.37 |
| Positive opinion for marketing authorisation date | 25 July 2019 | Merz — Inbrija EMA EPAR public assessment report (EMEA/H/C/0, p.10 |
Source documents
Explore the full evidence
All 386 cited findings for Inbrija — searchable, comparable and answerable in plain language — are in the Neurology research library →
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.