Inbrija Approval History
Reviewed by J.Stewart BPharm. Last updated on Dec 30, 2018.
Inbrija (levodopa) is an oral inhalation formulation of the approved drug levodopa for the treatment of OFF episodes in people with Parkinson’s disease taking a carbidopa/levodopa regimen.
- OFF periods in Parkinson’s disease result from low levels of dopamine between doses of carbidopa/levodopa, and they can be unpredictable and appear more frequently over time. The absorption of oral medication can be variable and contribute to the development of OFF periods. Inbrija enters the bloodstream directly via the lungs and does not depend on absorption in the digestive tract.
- Inbrija is for oral inhalation only, and the Inbrija capsules must NOT be swallowed. The inhaler can be used up to five times daily, and is breath-actuated so does not need to be pressed or manipulated in coordination with inhalation. The inhaler makes a unique "whirl" (spin) sound so the user knows the inhaler is working and the medicine is being delivered.
- Inbrija is contraindicated in patients currently taking, or who have recently taken a nonselective monoamine oxidase (MAO) inhibitor. The effectiveness of Inbrija may be reduced in patients taking dopamine D2 receptor antagonists (phenothiazines, butyrophenones, risperidone, metoclopramide), isoniazid, and iron salts or multivitamins containing iron salts.
- Patients should tell their healthcare provider if they experience the following serious side effects: falling asleep during normal daily activities, withdrawal-emergent hyperpyrexia and confusion, low blood pressure, hallucinations and other psychosis, unusual uncontrollable urges, dyskinesia, and bronchospasm. Inbrija is not recommended in patients with asthma, COPD, or other chronic underlying lung disease.
- The most common adverse reactions (incidence ≥ 5%) were cough, nausea, upper respiratory tract infection, and discolored sputum.
Development History and FDA Approval Process for Inbrija
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