FDA APPROVES INBRIJA

FDA Approves Inbrija (levodopa inhalation powder) for Intermittent Treatment of OFF Episodes in People with Parkinson’s Disease

ARDSLEY, NY–(Business Wire) December 21, 2018 — Acorda Therapeutics, Inc today announced that the US Food and Drug Administration approved Inbrija™ for the intermittent treatment of OFF episodes in people with Parkinson’s disease treated with carbidopa/levodopa. OFF episodes, also known as OFF periods, are defined as the return of Parkinson’s symptoms that result from low levels of dopamine between doses of oral carbidopa/levodopa, the standard oral baseline Parkinson’s treatment. 
    FDA approval of Inbrija was based on a clinical program that included approximately 900 people with Parkinson’s on a carbidopa/levodopa regimen experiencing OFF periods. Inbrija is not to be used by patients who take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last two weeks. 
About the Inbrija (levodopa inhalation powder) Clinical Development Program 
The Phase 3 pivotal efficacy trial—SPANSM-PD—was a 12-week, randomized, placebo-controlled, double-blind study evaluating the effectiveness of Inbrija in patients with mild to moderate Parkinson’s experiencing OFF periods. 
    The SPAN-PD trial met its primary endpoint, with patients showing a statistically significant improvement in motor function at the Week 12 visit, as measured by a reduction in Unified Parkinson’s Disease Rating Scale (UPDRS) Part III score for Inbrija 84 mg (n=114) compared to placebo (n=112) at 30 minutes post-dose (-9.83 points and -5.91 points respectively; p=0.009). The onset of action was seen as early as 10 minutes. 
    The most common adverse reactions with Inbrija (at least 5% and greater than placebo) in the pivotal trial were cough (15% vs. 2%), upper respiratory tract infection (6% vs. 3%), nausea (5% vs. 3%) and sputum discolored (5% vs. 0%). 
    Inbrija was also studied in a Phase 3 long-term, active-controlled, randomized, open-label study (n=398) assessing safety and tolerability over one year. This study showed the average reduction in FEV1 (forced expiratory volume in 1 second) from baseline was the same (-0.1 L) for the Inbrija and observational cohorts. Patients with chronic obstructive pulmonary disease (COPD), asthma, or other chronic respiratory disease within the last five years were excluded from this study. 
    Inbrija is expected to be commercially available by prescription in the U.S. in the first quarter of 2019 and will be distributed through a network of specialty pharmacies.
ADDITIONAL IMPORTANT SAFETY INFORMATION
Before using Inbrija, patients should tell their healthcare provider about all their medical conditions, including:
•    asthma, chronic obstructive pulmonary disease (COPD), or any chronic lung disease
•    daytime sleepiness from a sleep disorder or if they get drowsy/sleepy without warning or take a medicine that increases sleepiness such as sleep medicines, antidepressants, or antipsychotics
•    feel dizzy, nausea, sweaty, or faint when standing from sitting/lying down
•    history of abnormal movement (dyskinesia)
•    mental health problem such as hallucinations or psychosis
•    uncontrollable urges (for example, gambling, increased sexual urges, intense urges to spend money, or binge eating)
•    glaucoma
•    pregnancy or plans to become pregnant. It is not known if Inbrija will harm an unborn baby.
•    breastfeeding or plans to breastfeed. Levodopa (the medicine in Inbrija) can pass into breast milk, and it is unknown if it can harm the baby.
Patients should tell their healthcare provider if they take:
•    MAO-B inhibitors;
•    dopamine D2 receptor antagonists (including phenothiazines, butyrophenones, risperidone, metoclopramide), or isoniazid;
•    iron salts or multivitamins that contain iron salts.
No more than 1 dose (2 capsules) should be taken for any OFF period. No more than 5 doses (10 capsules) of Inbrija should be taken in a day.
    Inbrija is for oral inhalation only. Inbrija capsules are not to be swallowed or opened.
    Patients are not to drive, operate machinery, or do other activities until they know how Inbrija affects them. Sleepiness and falling asleep suddenly can happen as late as a year after treatment is started.
Inbrija (levodopa inhalation powder) can cause serious side effects. Patients should tell their healthcare provider if they experience the following:
Falling asleep during normal daily activities (such as driving, doing physical tasks, using hazardous machinery, talking, or eating) and can be without warning. If patients become drowsy while using Inbrija, they should not drive or do activities where they need to be alert. Chances of falling asleep during normal activities increases if patients take medicines that cause sleepiness.
Withdrawal-emergent hyperpyrexia and confusion (symptoms including fever, confusion, stiff muscles, and changes in breathing and heartbeat) in patients who suddenly lower or change their dose or stop using Inbrija or carbidopa/levodopa medicines.
Low blood pressure with or without dizziness, fainting, nausea, and sweating. Patients should get up slowly after sitting or lying down.
Hallucinations and other psychosis. Inbrija may cause or worsen psychotic symptoms including hallucinations (seeing/hearing things that are not real); confusion, disorientation, or disorganized thinking; trouble sleeping; dreaming a lot; being overly suspicious or feeling people want to harm them; believing things that are not real, acting aggressive, and feeling agitated/restless.
Unusual uncontrollable urges such as gambling, binge eating, shopping, and sexual urges has occurred in some people using medicines like Inbrija.
Uncontrolled, sudden body movements (dyskinesia) may be caused or worsened by Inbrija. Inbrija may need to be stopped or other Parkinson’s medicines may need to be changed.
Bronchospasm – people with asthma, COPD, or other lung diseases may wheeze or have difficulty breathing after inhaling Inbrija. If patients have these symptoms, they should stop taking Inbrija and call their healthcare provider or go to the nearest hospital emergency room right away.
Increased eye pressure in patients with glaucoma. Healthcare providers should monitor this.
Changes in certain lab values including liver tests.
The most common side effects of Inbrija include cough, upper respiratory tract infection, nausea, and change in the color of saliva or spit.