Patient Global Impression of Change

Actor portrayal.

Based on the prespecified statistical hierarchy in the pivotal phase 3 clinical trial, Patient Global Impression of Change (PGIC) and OFF time were not eligible for statistical significance; however, analysis was conducted and nominal P values are provided for descriptive purposes, but conclusions cannot be drawn.¹³

MORE INBRIJA PATIENTS REPORTED IMPROVEMENT IN PGIC COMPARED WITH PLACEBO AT WEEK 12^11,13

*P<0.001; the nominal P value was not statistically significant per the prespecified hierarchy.¹³

Percentage of responses to survey question: “How has the addition of study drug changed your Parkinson’s disease?”¹¹

Change in total daily OFF time^11,13

Patients’ self-reported accounting of PD symptoms completed at home over 3 days showed no differences in the reduction in mean total daily OFF time from baseline (P=0.975).

• INBRIJA -0.47 hours (n=114) vs placebo -0.48 hours (n=112)

INBRIJA HUB prescription data

~70%

of patients who used on average at least 1 dose per day were still on INBRIJA after 1 year, according to real-world prescription data (N=4093)¹¹

Data as of December 2023

SEE REAL
INBRIJA RESULTS

ENDPOINT^11,13	STEP	INBRIJA 84 mg (n=114)	PLACEBO (n=112)	P Value
Change in UPDRS Part III at 30 min	1 (Primary)	-9.83	-5.91	0.009
% Achieving ON and remaining ON at 60 min	2	57.7%	36.1%	0.003
Change in UPDRS Part IlI at 20 min*	3	-9.04	-6.49	0.062
% Patients improved on PGIC	4	71.4%	46.4%	<0.001^†
Change in UPDRS Part III at 10 min	5	-6.45	-4.18	0.046^†
Change in PD diary OFF time (hr/day)	6	-0.47	-0.48	0.975

*As this hierarchical step was not statistically significant, all subsequent steps were not eligible for statistical significance.

^†Nominal P values; not statistically significant per prespecified hierarchy.

INBRIJA^® Indication

INBRIJA® (levodopa inhalation powder) is indicated for intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD) treated with carbidopa/levodopa.

Important Safety Information

CONTRAINDICATIONS

INBRIJA is contraindicated in patients taking or who have recently taken (within 2 weeks) nonselective monoamine oxidase (MAO) inhibitors (e.g., phenelzine and tranylcypromine) due to risk of hypertension.

WARNINGS AND PRECAUTIONS

Patients treated with levodopa have reported falling asleep during activities of daily living, including operation of motor vehicles, which sometimes resulted in accidents. Many patients reported somnolence but some reported no warning signs (sleep attack). Some of these events were reported more than a year after initiating treatment. Reassess patients for drowsiness/sleepiness including occurrence during specific activities. Advise patients of potential for drowsiness and ask about factors that may increase this risk.

Consider discontinuing INBRIJA in patients who report significant daytime sleepiness or falling asleep during activities that require active participation. If continuing INBRIJA, advise patients not to drive and to avoid activities that may result in harm. There is insufficient information that dose reduction will eliminate episodes of falling asleep during activities of daily living.

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 and abnormal thinking and behavior may occur. Because of the risk of exacerbating psychosis, patients with a major psychotic disorder should ordinarily not be treated with INBRIJA and dopamine antagonists used to treat psychoses may exacerbate PD symptoms and decrease the effectiveness of INBRIJA.
Patients treated with 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.
INBRIJA may cause or exacerbate dyskinesias. If troublesome dyskinesias occur, consider stopping INBRIJA or adjusting other PD medications.
INBRIJA is not recommended in patients with asthma, COPD, or other chronic underlying lung disease because of the risk of bronchospasm.
Monitor patients with glaucoma for increased intraocular pressure.
Abnormalities in laboratory tests may include elevations of liver function tests (e.g., alkaline phosphatase, AST, ALT, lactic dehydrogenase, bilirubin), blood urea nitrogen, hemolytic anemia, and positive direct antibody test. Increased levels of catecholamines and their metabolites in plasma and urine may result in false-positive results suggesting pheochromocytoma.

ADVERSE REACTIONS

The most common adverse reactions (≥ 5% and higher than placebo) were cough (15% vs 2%), upper respiratory tract infection (6% vs 3%), nausea (5% vs 3%), and sputum discolored (5% vs 0%).

DRUG INTERACTIONS

Use of selective MAO-B inhibitors with INBRIJA may be associated with orthostatic hypotension. Monitor patients taking these drugs concurrently. Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone, metoclopramide) and isoniazid may reduce levodopa efficacy; monitor patients for worsening PD symptoms. Iron salts or multivitamins with iron salts may reduce levodopa bioavailability.

USE IN PREGNANCY AND LACTATION

There are no adequate data on the developmental risk associated with INBRIJA in pregnant women or on the effects on breastfed infants. Animal data shows carbidopa/levodopa is developmentally toxic (including teratogenicity). Levodopa may interfere with lactation. Levodopa has been detected in human milk.

PEDIATRIC USE

Safety and effectiveness in pediatric patients have not been established.

GERIATRIC USE

Patients 65 years of age and older (n=56) experienced more of the following adverse reactions than patients <65 (n=58): cough (25% vs 5%), upper respiratory tract infection (11% vs 2%), nausea (7% vs 3%), vomiting (4% vs 2%), pain in extremities (4% vs 0%), and discolored nasal discharge (4% vs 0%).

Visit www.inbrija-hcp.com to obtain the Full Prescribing Information, Patient Information and Instructions for Use.

IMPORTANT SAFETY INFORMATION

INBRIJA is contraindicated in patients taking or who have recently taken (within 2 weeks) nonselective monoamine oxidase (MAO) inhibitors (e.g., phenelzine and tranylcypromine) due to risk of hypertension.

WARNINGS AND PRECAUTIONS

Patients treated with levodopa have reported falling asleep during activities of daily living, including operation of motor vehicles, which

Patients taking INBRIJA reported improvement in their Parkinson's disease