23 February 2018 - - The US Food and Drug Administration has accepted US-based biopharmaceutical company Acorda Therapeutics, Inc.'s (NASDAQ: ACOR) new drug application (NDA) for Inbrija, an investigational inhaled levodopa treatment for symptoms of OFF periods in people with Parkinson's disease taking a carbidopa/levodopa regimen, the company said.
Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of October 5, 2018.
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, that 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.
Inbrija utilizes Acorda's investigational ARCUS platform for inhaled therapeutics. It was designed to deliver a precise dose of a dry powder formulation of L-dopa to the lung.
Acorda Therapeutics is focused on developing therapies that restore function and improve the lives of people with neurological disorders. The company has a pipeline of novel neurological therapies addressing a range of disorders, including Parkinson's disease and multiple sclerosis.