Safety and Tolerability of INBRIJA For Early Morning OFF
Early Morning OFF Safety Results8:
- A randomized, placebo-controlled, double-blind, 2-way crossover study with 1:1 randomization to 2 crossover dosing periods to evaluate the safety and tolerability of INBRIJA for early morning OFF
- Patients withheld oral CD/LD overnight and in the morning until arriving at study site. Last oral CD/LD dose was taken more than 8 hours prior to study treatment
- Patients in an OFF state used INBRIJA 84 mg or placebo immediately after the first oral CD/LD dose on the study day
- Key inclusion and exclusion criteria were the same as for SPANSM-PD
Mean Baseline Characteristics (N=36) Age (range, 39-81 yr) 62.9 yr Gender (male)* 58.3% Ethnicity (white)* 94.4% Time since diagnosis 7.9 yr Daily oral levodopa dose 727.5 mg Oral levodopa morning dose 183.8 mg
*Not mean value
Adverse Reactions Occurring in ≥5% of INBRIJA-treated Patients and at a Higher Rate Than Placebo8
Adverse Reaction | INBRIJA 84 mg n=36 n (%) | PLACEBO n=36 n (%) |
---|---|---|
Cough | 4 (11.1) | 1 (2.8) |
Moderate dyskinesia | 2 (5.6) | 1 (2.8) |
- There were no discontinuations due to adverse reactions
A single dose of INBRIJA administered immediately after oral CD/LD for early morning OFF resulted in no additional safety concerns