FDA approves Inbrija
Acorda Therapeutics, Inc.
Acorda Therapeutics, Inc. recently announced that the U.S. Food and Drug Administration approved Inbrija for intermittent treatment of OFF episodes in people with Parkinsons disease treated with carbidopa/levodopa. OFF episodes, also known as OFF periods, are defined as the return of Parkinsons symptoms that result from low levels of dopamine between doses of oral carbidopa/levodopa, the standard oral baseline Parkinsons treatment.
Todays approval of Inbrija marks a major milestone for both Acorda and the Parkinsons community, for whom we are gratified to have developed this much needed therapy, said Ron Cohen, M.D., Acorda President and CEO. This milestone resulted from over two decades of research and development, beginning in the laboratory of Dr. Robert Langer at Massachusetts Institute of Technology, through years of enormous perseverance and ingenuity by the entire Acorda team.
Despite being on treatment, patients may experience OFF periods as Parkinsons progresses, which can be disruptive, said Todd Sherer, Ph.D., CEO, The Michael J. Fox Foundation. The Foundation provided funding for the early clinical development of Inbrija because patients told us that OFF periods were one of their most serious issues. We knew we had to help address this unmet need, and this approval is a significant step forward for the community as it provides a new option to manage these gaps in symptom control.
FDA approval of Inbrija was based on a clinical program that included approximately 900 people with Parkinsons 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.
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 breastmilk 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 including the following. Patients should tell their healthcare provider if they experience them:
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 Parkinsons 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.
