Posted by Michael Wonder on 20 Feb 2018
Acorda announces FDA acceptance of new drug application for Inbrija (levodopa inhalation powder)
20 February 2018 - Acorda Therapeutics today announced that the U.S. FDA has accepted for filing its new drug application for Inbrija.
Inbrija is an investigational inhaled levodopa treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen. Under the Prescription Drug User Fee Act, the FDA has set a target date of 5 October 2018.
The application for Inbrija includes data from a Phase 3 safety and efficacy study (SPAN-PD), as well as results from two long-term safety studies in people with Parkinson’s disease. Findings from these studies support the filing of Inbrija for use on an as-needed basis to address symptoms of OFF periods in patients on a carbidopa/levodopa regimen.
