For US Healthcare Professionals

New Parkinson's Therapy for
On-demand use to treat OFF Periods

For patients on carbidopa/levodopa
NOW AVAILABLE
Orally Inhaled Levodopa

About OFF Periods

Many people with Parkinson’s fluctuate between ON states during which their symptoms are controlled and OFF episodes (also known as OFF periods) when their symptoms return.1,2 OFF periods may occur even when patients are taking their usual CD/LD-containing Parkinson’s regimen.3
  • OFF periods can be disruptive and occur during any stage of Parkinson’s disease4,5
    • An online survey of more than 3,000 individuals with Parkinson’s conducted by the Michael J. Fox Foundation found that 70% experienced at least 2 OFF periods per day4

Types of OFF Periods2,6,7

  • Morning OFF

    OFF symptoms experienced upon waking

  • Wearing OFF

    Characterized by the return of symptoms prior to the next scheduled CD/LD dose

  • Delayed "ON" Response

    When a dose takes longer than anticipated to improve symptoms

  • Unexpected OFF

    Sudden and sometimes random transition from ON to OFF

  • Dose Failure

    When a dose does not provide improvement in symptoms

Factors That May Contribute to OFF Periods

  • Oral levodopa, typically combined with the dopa decarboxylase inhibitor carbidopa, is highly effective and the gold standard for baseline Parkinson’s therapy.8 However, gastrointestinal (GI) issues related to Parkinson’s, including erratic and slowed gastric emptying, may result in delayed absorption or variable levodopa levels, contributing to OFF periods.9
  • The variability in oral delivery that can occur from competition for uptake with dietary amino acids/food effect in the GI tract may also contribute to the development of OFF periods.10
Route of oral CD/LD administration

Pulmonary Delivery With INBRIJATM

INBRIJA, the inhaled form of levodopa, offers systemic delivery via the pulmonary route. Because it is inhaled, INBRIJA bypasses the GI issues that can contribute to variable absorption of oral CD/LD and the occurrence of OFF periods.11

In the pivotal clinical trial, onset of action of INBRIJA 84 mg was seen as early as 10 minutes postdose.

Route of oral CD/LD administration

Selected Important Safety Information

  • INBRIJA is not recommended in patients with asthma, COPD, or other chronic underlying lung disease because of the risk of bronchospasm.
  • Iron salts or multivitamins with iron salts may reduce levodopa bioavailability.

Please see additional Important Safety Information below.

For Patients on CD/LD

INBRIJA Significantly Improves Motor Function During OFF Periods

Onset of action with INBRIJA was seen as early as 10 minutes postdose. Significant improvement in motor function was seen at 30 minutes post-dose.

Inbrija product placement

SPANSM‑PD Pivotal Trial

Study Design12,13

The 12‑week, randomized, double‑blind, placebo‑controlled SPAN‑PD study evaluated the efficacy and safety of INBRIJA for treatment of OFF periods in patients with Parkinson’s.

  • SPAN‑PD was a multinational trial (US, Canada, Poland, and Spain)
  • A total of 114 patients were treated with INBRIJA 84 mg (two 42‑mg capsules), and 112 patients received placebo
  • At weeks 0, 4, 8, and 12, patients underwent efficacy evaluations at a clinic
key inclusion/Exclusion criteria
INCLUSION
  • Modified Hoehn and Yahr Stage 1 to 3 (mild to moderate), as measured in ON state
  • ≥2 hours of OFF time per day
  • CD/LD regimen not exceeding 1600 mg/day of levodopa
EXCLUSION
  • Asthma, COPD, or other chronic respiratory disease within the last 5 years

Usual-care aspects12

The SPAN‑PD trial reflected the way patients would actually use INBRIJA on-demand for OFF periods in addition to their CD/LD‑based Parkinson’s therapy.

  • Study drug taken at the onset of an OFF period (return of symptoms)
  • Patients continued taking their usual Parkinson’s medications
  • Self-administration up to a maximum of 5 times per day
Baseline Patient Characteristics (N=226)13
Mean value
Age (range, 38-82 yr) 63.0 yr
Gender 75% male
Ethnicity 95% white
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

The mean UPDRS Part III scores at screening in the ON state were 14.9 for patients randomized to INBRIJA 84 mg and 16.1 for patients randomized to placebo.

Medications used in addition to CD/LD13

  • 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.

Selected Important Safety Information

  • Use of selective MAO-B inhibitors with INBRIJA may be associated with orthostatic hypotension. Monitor patients taking these drugs concurrently.

Please see additional Important Safety Information below.

Primary Endpoint

  • Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III motor score from predose OFF state to 30 minutes postdose with INBRIJA 84 mg vs placebo at week 12
  • The UPDRS Part III motor exam assesses the severity of primary Parkinson’s symptoms

Selected Important Safety Information

  • 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.
  • Please see additional Important Safety Information below.

Efficacy Results: INBRIJA Significantly Improves Motor Function in Patients With Parkinson's on CD/LD Experiencing OFF Periods

Primary endpoint met: significant improvement with INBRIJA 84 mg vs placebo in UPDRS Part III motor score at week 12 (P=0.009)

UPDRS Part III Score Change From 0-60 Minutes Postdose at Week 12

Inbrija efficacy chart
Inbrija efficacy chart

SE, standard error.

  • Onset of action: as early as 10 minutes postdose
  • Primary endpoint: significant improvement in motor function at 30 minutes postdose (P=0.009)
  • Continuation of effect: at 60 minutes postdose
  • Average use of INBRIJA 84 mg: ~2 doses per day

Safety Results

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.

Prescribing INBRIJA

Dosing

  • One dose (84 mg) = two 42-mg capsules
  • No more than 1 dose per OFF period
  • May be taken as needed up to a maximum of 5x per day when symptoms start to return
    • Average number of doses in clinical trials: ~2 per day13

Important Administration Instructions

  • For oral inhalation only; INBRIJA capsules must not be swallowed as intended effect would not be obtained
  • INBRIJA capsules are only for use with the INBRIJA inhaler
  • Effective only in combination with CD/LD
  • Capsules should be stored in their blister package and only removed immediately before use
Demonstrated
Usability
99.8%
(628/629)
of randomized patients in the 2 clinical trials demonstrated the ability to self-administer INBRIJA while in an OFF period after instruction13

Steps for Prescribing INBRIJA

GETTING PATIENTS STARTED ON INBRIJA. HERE'S HOW:

Complete a Prescription Request Form (PRF)

  • Fill in the information and sign and date the form
  • Fax the completed form to Prescription Support Services at 1-855-886-2484

Prescription Support Services conducts benefits investigation

  • Specialists work directly with patient's health insurance plan to determine coverage and assist with reimbursement
  • If your patient’s health plan does not cover INBRIJA, a specialist will explore other options

Prescription Support Services calls patient directly

  • After determining coverage, a specialist will call your patient to:
    • Review coverage and financial assistance options (if eligible)
    • Ensure your patient knows how to use INBRIJA
    • Let your patient know which specialty pharmacy will handle their prescription

Speciality pharmacy delivery of INBRIJA

  • Specialty pharmacy arranges delivery of INBRIJA
  • Specialty pharmacy facilitates refills and reauthorizations
Should you have any questions,
please call Prescription Support Services:

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INBRIJA Product Support

Prescription Support Services

The Prescription Support Services program is available to provide ongoing support throughout the prescription and fulfillment process.

To learn more, call 1-888-887-3447.

Request a Representative

Contact us to find out how INBRIJA can help patients with Parkinson's who are experiencing OFF periods between their regular doses of CD/LD.

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Indication

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

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.

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.

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