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 (PDUFA), the FDA has set a target date of October 5, 2018.
Acorda chief medical officer Burkhard Blank said: “OFF periods greatly disrupt the lives of people living with Parkinson’s, and there is a significant need for new treatments in this community.
“We are excited about the potential to bring this highly innovative treatment option to people living with Parkinson’s, and look forward to working with the FDA throughout the review process.”
The NDA 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.
Data from the SPAN-PD trial were presented at the International Congress of Parkinson’s Disease and Movement Disorders (MDS) in June 2017.
The Michael J. Fox Foundation CEO Todd Sherer said: “People with Parkinson’s and physicians need more options to manage this disease.
“Inhaled delivery of levodopa could help the many people living with Parkinson’s facing the complication of OFF periods as their disease progresses.”
The INBRIJA Phase I and II clinical studies were funded in part by grants from The Michael J. Fox Foundation for Parkinson’s Research.