Acorda Therapeutics announced that the U.S. FDA approved Inbrija for intermittent treatment of OFF episodes in people with Parkinson’s disease treated with carbidopa/levodopa.
Back in September, the FDA delayed its Inbrija verdict by three months after Acorda submitted additional information regarding chemistry, manufacturing and controls at the regulatory body’s request. The submissions were deemed a major amendment to the new drug application (NDA) and required more time to reassess.
The product is the first and the only approved inhaled levodopa for treating OFF periods in patients suffering Parkinson’s and receiving a carbidopa/levodopa regimen. OFF periods are the return of Parkinson’s symptoms that result from low levels of dopamine between doses of oral carbidopa/levodopa, the standard oral baseline Parkinson’s treatment.
The NY-based biotech said it expects the treatment to be available by prescription in the first quarter of 2019.
Read the press release