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In 10 minutes

INBRIJA can start to get patients back to living their everyday moments

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Rapid onset of action in
as early as 10 minutes post dose13

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Significant improvement in motor function post dose (P=0.009) (primary endpoint)13

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Sustained effect post dose13

SPANSM-PD was a 12-week, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of INBRIJA for the treatment of OFF periods in patients with PD treated with CD/LD

SPAN-PD: Study Design11,13 (N=226)

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WEEK

USE AT HOME11,13

  • Used at the start of an OFF period

  • Continued use of usual PD medications, including CD/LD

  • Self-administered as needed up to a maximum of 5 times during the waking day

IN-CLINIC DOSING AT WEEKS 0, 4, 8, AND 1211,13

  • Took morning CD/LD as usual and arrived in the ON state

  • Remained in clinic until they transitioned into an OFF period

  • Self-administered study drug at the start of the OFF period

Primary endpoint

UPDRS Part III* motor score at 30 minutes: change from predose OFF to 30 minutes post dose with INBRIJA 84 mg vs placebo

UPDRS Part III is a composite measure of 14 items designed to assess the severity of primary motor symptoms (eg, tremor, rigidity, bradykinesia, postural instability) in patients with PD. Disability level is evaluated using 27 assessments with a total score of 108 points.15
UPDRS, Unified Parkinson's Disease Rating Scale.

Select baseline criteria for the SPAN-PD study

  • CD/LD regimen not exceeding 1600 mg/day of levodopa

  • ≥2 hours of OFF time per day

  • Hoehn and Yahr stage <2.5 (64.6% of patients)11

  • Mean UPDRS Part III motor scores in ON stage at screening: 14.9 for INBRIJA 84 mg and 16.1 for placebo

  • Patients with asthma, chronic obstructive pulmonary disease (COPD), or other chronic respiratory disease11

  • Use of apomorphine13

Mean Patient Baseline Charcteristics (N=226)11,13

Age (range, 38-82 yr) 63.0 yr
Gender (male)† 75%
Ethnicity (white)† 95%
Time since diagnosis 8.0 yr
Number of OFF periods per day‡ 3.4
Duration of oral levodopa treatment 6.5 yr
Daily oral levodopa dose 830 mg
Number of daily oral levodopa doses 5.1

†Not mean value.
‡Includes early morning OFF.

  • Dopamine agonists (57.5%)

  • Selective MAO-B inhibitors (38.9%)

  • Adamantane derivatives (19.9%)

  • COMT inhibitors (14.2%)

COMT, catechol-O-methyltransferase; MAO-B, monoamine oxidase B.

INBRIJA starts to work in 10 minutes so patients can get back in charge of their day

UPDRS Part III score change from 0 to
60 minutes post dose at week 12

chart chart SE, standard error.

Responder ON

A significantly greater proportion of patients taking INBRIJA 84 mg (58%) returned to ON state and sustained that ON through 60 minutes post dose vs placebo (36%; P=0.003) (first secondary endpoint)13

INBRIJA has an established safety profile

Adverse Reactions Occurring in ≥5% of INBRIJA-treated Patients and at a Higher Rate Than Placebo

INBRIJA 84 mg
(n=114)		 PLACEBO
(n=112)
Cough 15% 2%
Upper respiratory tract infection 6% 3%
Nausea 5% 3%
Discolored sputum 5% 0%

  • 2% of 114 participants discontinued INBRIJA 84 mg due to cough

  • 5% of participants taking INBRIJA 84 mg discontinued due to any adverse reactions, compared with 3% of patients taking placebo

  • Inhalation of INBRIJA can lead to coughing or the sensation of choking* at the time of administration

*Sensation of choking was identified during postapproval use of INBRIJA.

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INBRIJA® Indication

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

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. Discontinue use of nonselective MAO inhibitors at least 2 weeks prior to initiating INBRIJA.
  • Patients treated with levodopa, the active ingredient in INBRIJA, 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). This may occur 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 (e.g., sedating medications, sleep disorders).
    • 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 (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.
  • 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.
  • The most common adverse reactions (≥ 5% and > placebo) were cough (15% vs 2%), upper respiratory tract infection (6% vs 3%), nausea (5% vs 3%), and sputum discolored (5% vs 0%).
  • 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 for worsening symptoms.
  • Iron salts or multivitamins with iron salts may reduce levodopa bioavailability.
  • INBRIJA should be used during pregnancy/nursing only if potential benefit justifies potential risk. There are no adequate data on INBRIJA in pregnant women or breastfed infants. Animal data shows carbidopa/levodopa is developmentally toxic (including teratogenicity). Levodopa may affect milk production, interfering with lactation. Levodopa has been detected in human milk.
  • Safety and effectiveness in pediatric patients have not been established.
  • Geriatric patients (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%).

Please see the Full Prescribing Information.

INBRIJA® Indication

Intermittent treatment of OFF episodes in patients with PD treated with CD/LD.

Important Safety Information

Contraindicated in patients taking or who have recently taken (within 2 weeks) nonselective monoamine oxidase (MAO) inhibitors (e.g., phenelzine and tranylcypromine) due to hypertension risk. Discontinue use of nonselective MAO inhibitors at least 2 weeks prior to initiating INBRIJA.

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