Primary endpoint met: significant improvement with INBRIJA 84 mg vs placebo in UPDRS Part III motor score at week 12 (P=0.009)
SPAN-PD: Adverse Reactions Occurring in ≥5% of INBRIJA-Treated Patients and at a Higher Rate Than Placebo
|Adverse Reaction ||INBRIJA 84 mg (n=114) ||Placebo (n=112) |
|Cough ||15% ||2% |
|Upper respiratory tract infection ||6% ||3% |
|Nausea ||5% ||3% |
|Sputum discolored ||5% ||0 |
|SPAN-PD: Discontinuations Due to Adverse Reactions |
| INBRIJA 84 mg: 6 patients (5%) |
| Placebo: 3 patients (3%) |
- Inhalation of INBRIJA can lead to coughing at the time of administration
- The most common adverse reaction leading to discontinuation of INBRIJA 84 mg was cough (2 patients)
No Notable Effect on Pulmonary Function: 1‑Year Safety Study
A randomized, controlled, open-label study assessed the effect of INBRIJA 84 mg on pulmonary function vs a control group observed on their regular PD medications over 1 year.
- Patients were assigned to either INBRIJA 84 mg (two 42‑mg capsules) no more than 5x/day as needed to treat OFF periods (n=271), or to an observational cohort (n=127)
- Patients with asthma, COPD, or other chronic respiratory disease within the last 5 years were excluded
- Pulmonary function was assessed every 3 months
At the end of 1 year, the average reduction from baseline in forced expiratory volume in 1 second (FEV1) was the same in both groups (-0.1 L).
Selected Important Safety Information
- Neuroleptic malignant syndrome-like symptoms (e.g., elevated temperature, muscular rigidity, altered consciousness, autonomic instability) have been reported with rapid dose reduction, withdrawal of, or changes in dopaminergic therapy.
- Hallucinations (with or without confusion, insomnia, and excessive dreaming) may occur and may respond to reducing levodopa therapy. Abnormal thinking and behavior may present with paranoid ideation, delusions, hallucinations, confusion, psychotic-like behavior, disorientation, aggressive behavior, agitation and delirium.
- INBRIJA should ordinarily not be used in patients with major psychotic disorder due to risk of exacerbating psychosis. Dopamine antagonists used to treat psychosis may exacerbate symptoms of PD and may decrease INBRIJA efficacy.
- Patients on medications that increase central dopaminergic tone such as INBRIJA can experience intense urges to gamble or spend money, increased sexual urges, binge eating, and/or other intense urges, and inability to control them. In some cases, these urges stopped with dose reduction or medication discontinuation. Since some patients may not recognize these behaviors as abnormal, ask patients or their caregivers about development of new or increased urges and consider stopping INBRIJA if this occurs.
Please see additional Important Safety Information below.