1-Year Safety Study

Results from a 12-month study

After 1 year, the average reduction in forced expiratory volume in 1 second (FEV₁) from baseline was the same in both the INBRIJA® group and observational cohort (-0.1 L).²³

A randomized, controlled, open-label study assessed the effect of INBRIJA 84 mg (n=271) on pulmonary function vs a control group (n=127) observed on their regular PD medications over 1 year.

Subjects included patients with PD treated with oral CD/LD and having return of PD symptoms

Patients with COPD, asthma, or other chronic
respiratory disease were excluded

Pulmonary function was assessed by spirometry
every 3 months in both groups

The most common adverse reactions (≥5% of INBRIJA‑treated patients and at a higher rate than observational cohort) were cough (13.3% vs 0.8%), fall (8.1% vs 5.5%), nasopharyngitis (6.6% vs 5.5%), and dyskinesia (6.3% vs 3.9%)

Of the 36 patients who reported cough, 28 (78%) were within the first 30 days of treatment

The most common adverse reaction leading to discontinuation was cough in 3 patients in the INBRIJA cohort

There were no discontinuations due to adverse reactions in the observational cohort

CD/LD, carbidopa/levodopa; COPD, chronic obstructive pulmonary disease; PD, Parkinson's disease.

1-year safety extension study on pulmonary function23

Results from a 12-month study

1-year safety extension study on pulmonary
function²³