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.
This Week's Must Reads
Must Reads in FDA Actions
FDA Approves Inbrija for PD OFF Episodes, Acorda Therapeutics news release; 2018 Dec 21
FDA Approves Firdapse for Rare Autoimmune Disorder, FDA news release; 2018 Nov 28
FDA Approves Ajovy for Migraine in Adults, Teva Pharmaceutical news release; 2018 Sep 14
FDA Approves Tiglutik for Treatment of ALS, ITF Pharma news release; 2018 Sep 6
FDA Approves Diacomit for Treatment of Seizures, Biocodex news release; 2018 Aug 23