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FDA Approves Inbrija for PD OFF Episodes

Acorda Therapeutics news release; 2018 Dec 21

Acorda Therapeutics, Inc. recently announced that the US Food and Drug Administration (FDA) has approved Inbrija for intermittent treatment of OFF episodes in people with Parkinson disease (PD) treated with carbidopa/levodopa. OFF episodes, also known as OFF periods, are defined as the return of Parkinson symptoms that result from low levels of dopamine between doses of oral carbidopa/levodopa, the standard oral baseline Parkinson treatment. Acorda Therapeutics is headquartered in Ardsley, NY.

Indications: Inbrija is an aromatic amino acid indicated for the intermittent treatment of

OFF episodes in patients with PD treated with carbidopa/levodopa.

Dosage/administration: Inbrija is for oral inhalation only. Patients should not swallow Inbrija capsules, which should only be used with the Inbrija inhaler. Patients should inhale the contents of 2 Inbrija capsules (84 mg) as needed for OFF symptoms, up to 5 times daily. The maximum dose per OFF period is 84 mg, and the maximum recommended daily dosage of Inbrija is 420 mg.

Adverse reactions: The most common adverse reactions (incidence ≥5% and higher than

placebo) were cough, nausea, upper respiratory tract infection, and sputum discoloration.


Acorda Therapeutics announces FDA approval of Inbrija (levodopa inhalation powder). [news release]. Ardsley, NY: Acorda Therapeutics, Inc. December 21, 2018. Accessed January 18, 2019.