See Table 2 and Figure 1). The proportion ofpatients who returned to an ON state and sustained that ON through 60 minutes post-dose was
58% for INBRIJA 84 mg and 36% for placebo (p=0.003).
Table 2: Mean Change in UPDRS Part III Motor Score at 30 minutes post-dose(INBRIJA 84 mg) for the Intent-to-Treat Population at Week 12a
Treatment
Pre-dose (OFF)
UPDRS Part III
Motor Score
(mean)
Post-dose UPDRS
Part III Motor
Score
(mean)
Mean Change 30
minutes postdoseb,
c
Difference
from Placebo
(95%
confidence
internal) p-value
Placebo 32.1 25.3 -5.9 — —
INBRIJA 84 mg 29.0 19.3 -9.8 -3.92
(-6.84, -1.00)
0.009
a
Treatment group least-squares mean change is a model-based population estimate; the pre-dose and post-dose
means are descriptive statistics.
b
Least-squares mean.
c
Negative numbers indicate improvement as compared with the baseline value.
Figure 1: Least-squares Mean Change in UPDRS Part III Motor Score After
Administration of INBRIJA 84 mg vs. Placebo (at Week 12)
Study 2
The effect of INBRIJA on pulmonary function was eva luated in patients with Parkinson’sdisease treated with oral carbidopa/levodopa in a 12 month, randomized, controlled, openlabeledstudy (Study 2: NCT02352363). A total of 271 patients were treated with INBRIJA 84mg (two 42 mg capsules), and 127 patients with Parkinson’s disease in a control group wereobserved on their regular oral medication regimen for the treatment of Parkinson’s disease.
Patients with chronic obstructive pulmonary disease (COPD), asthma, or other chronicrespiratory disease within the last 5 years were excluded [see Warnings and Precautions (5.6)].
Pulmonary function was assessed by spirometry every 3 months in both groups. After 12months, the average reduction in the forced expiratory volume in 1 second (FEV1) from baselinewas the same in both groups (-0.1 L).
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
INBRIJA 42 mg contains foil blister strips of INBRIJA (levodopa inhalation powder) whitecapsules with two black bands on the body and “A42” in black on the cap, and one INBRIJAinhaler.
Carton containing 60 INBRIJA capsules (15 blister cards containing 4 capsules each)and 1 INBRIJA inhaler:
NDC 10144-342-60
Carton containing 92 INBRIJA capsules (23 blister cards containing 4 capsules each)
and 1 INBRIJA inhaler:
NDC 10144-342-92
INBRIJA inhaler consists of a blue cap, blue handle with “INBRIJA” imprinted on it, and whitemouthpiece covering the capsule chamber.
16.2 Storage and Handling
Store in a dry place between 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C(59°F to 86°F).
INBRIJA capsules should always be stored in the blister packaging and only removed
immediately before use. INBRIJA capsules should not be stored inside the INBRIJA inhaler.
INBRIJA capsules should be used only with the INBRIJA inhaler.
The INBRIJA inhaler should not be used to administer any other medicines.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information andInstructions for Use).
Instructions for Administering INBRIJAIt is important for patients to understand how to correctly administer INBRIJA. It isrecommended that patients be instructed in the proper administration of INBRIJA prior to use[see Dosage and Administration (2.1)].
Patients shoul |
