The Food and Drug Administration has approved INBRIJA™ for intermittent treatment of OFF episodes in people with Parkinson’s disease treated with carbidopa/levodopa, Acorda Therapeutics Inc. announced.
OFF episodes are when Parkinson’s symptoms return due to low levels of dopamine between doses of oral carbidopa/levodopa. The OFF periods can be disruptive and difficult for patients, and in a clinical study INBRIJA helped give meaningful improvements in motor function.
“Today’s approval of INBRIJA marks a major milestone for both Acorda and the Parkinson’s community, for whom we are gratified to have developed this much needed therapy,” said Ron Cohen, M.D., Acorda President and CEO.
FDA approval of INBRIJA was based on a clinical program that included around 900 people with Parkinson’s on a carbidopa/levodopa regimen experiencing OFF periods.