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Inbrija: The First and Only Inhaled Levodopa Approved by the FDA

The U.S. Food and Drug Administration (FDA) has approved Inbrija™ (levodopa inhalation powder) for the intermittent treatment of “off” episodes in people with Parkinson’s disease (PD) who are already treated with carbidopa/levodopa. Inbrija is an inhaled version of levodopa, providing a new method of delivery for the medication that is most commonly used to treat PD.1

What are “off” episodes?

Off” episodes, or “off” periods, are times when the person’s carbidopa/levodopa medication wears off or hasn’t yet taken effect, and symptoms of PD are more evident. “Off” episodes can interfere with daily activities and may be experienced multiple times a day. They may last a few minutes or as long as a few hours.2

How does Inbrija work?

PD damages the neurons in the brain that produce dopamine, an important neurotransmitter (chemical messenger) that is involved in smooth, purposeful movement. As the dopamine gets depleted, the motor symptoms of PD appear, such as tremor, rigidity, impaired balance, and loss of spontaneous movement. Levodopa, the active ingredient in Inbrija, is the precursor to dopamine and is converted into dopamine in the brain. Unlike other forms of levodopa which are taken orally and must go through the digestive process before getting into the bloodstream, Inbrija is inhaled and enters the body through the lungs, providing a quicker onset of action.3

In a 12-week clinical trial that included approximately 900 people with PD, patients who used Inbrija had a statistically significant improvement in their motor function compared to those who received placebo. The onset of action was seen as early as 10 minutes after Inbrija was inhaled.1

What are the common side effects with Inbrija?

The most common side effects seen in patients taking Inbrija in clinical trials included a cough, upper respiratory infection, nausea, and discolored sputum (saliva and mucus that is coughed up from the lungs).1,3

Inbrija may cause serious side effects, including:1,3

  • Falling asleep during normal daily activities, such as driving, talking, or eating
  • Low blood pressure with or without dizziness, fainting, nausea, or sweating
  • Hallucinations (hearing or seeing things that are not real) or other psychosis, confusion, or disorganized thinking
  • Unusual uncontrollable urges, such as gambling, binge eating, shopping, or sexual urges
  • Uncontrolled, sudden body movements (dyskinesia)
  • Bronchospasm (muscle spasm in the airways)
  • Increased eye pressure in people with glaucoma
  • Changes in certain blood tests including liver tests

Inbrija should not be stopped suddenly or without consulting a doctor. Some people who have suddenly stopped or lowered their dose of Inbrija have experienced withdrawal symptoms, including fever, confusion, stiff muscles, and changes in breathing and heartbeat.1,3

Things to know about Inbrija

Inbrija should not be taken in combination with MAO-B inhibitors, dopamine D2 receptor antagonists, iron salts, or multivitamins that contain iron salts. Patients should talk to their doctors about all their medications, vitamins, and herbal supplements before beginning treatment with Inbrija.1,3

No more than 1 dose should be taken for a particular “off” period, and no more than 5 doses of Inbrija should be taken in a day.1,3

  1. Acorda Therapeutics Announces FDA Approval of INBRIJA™ (levodopa inhalation powder). Business Wire. Available at https://www.businesswire.com/news/home/20181221005620/en/Acorda-Therapeutics-Announces-FDA-Approval-INBRIJA%E2%84%A2-levodopa. Accessed 12/27/18.
  2. Connolly BS, Lang AE. Pharmacological treatment of Parkinson disease: a review. JAMA. 2014 Apr 23-30;311(16):1670-83.
  3. Inbrija prescribing information. Available at http://www.inbrija.com/prescribing-information.PDF. Accessed 12/27/18.

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