Merz — Inbrija EMA EPAR public assessment report (EMEA/H/C/004786, 2019)
Merz · 2019 · EMA EPAR public assessment report
Report summary
This EMA report details the assessment of Inbrija (levodopa inhalation powder) for intermittent OFF episodes in adult Parkinson's disease patients, leading to a positive marketing authorization opinion in July 2019. The report confirms well-controlled pharmaceutical development and manufacturing. Non-clinical and clinical studies demonstrated rapid absorption, with the 84mg dose showing statistically significant improvement in UPDRS-III scores and a higher proportion of 'ON' responders compared to placebo. While cough was a common adverse event, and caution is advised for patients with lung disease, the overall benefit-risk balance for Inbrija is considered favorable.
Key findings — cited to the page
| Throat irritation leading to study discontinuation | 0.4 % | · p.75 |
| Throat irritation on first clinic visit day (Inbrija, Pool 3) | 2.4 % | Inbrija · p.66 |
| Throat irritation (Placebo, Pool 1) | 0.6 % | · p.66 |
| Upper respiratory tract irritation leading to study discontinuation | 0.3 % | · p.75 |
| Throat irritation (CVT-301, Pool 2) | 3.4 % | CVT-301 · p.66 |
| Throat irritation (Inbrija, Pool 1) | 3.3 % | Inbrija · p.66 |
| TEAEs related to route of administration Throat irritation | 0.6% | control · p.84 |
| Throat irritation incidence | 3.1% | CVT-301 Pool 2 · p.81 |
| TEAEs related to route of administration Throat irritation | 3.3% | CVT-301 Pool1 · p.84 |
| Throat irritation incidence | 0.6% | placebo · p.81 |
| Throat irritation incidence | 3.3% | CVT-301 Pool 1 · p.81 |
| TEAEs related to route of administration Throat irritation | 3.4% | CVT-301 Pool 2 · p.84 |
Source: Merz ↗ · 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 Neurology library →