Acorda Therapeutics, Inc. issued the following announcement on Feb. 20.
Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) 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 (PDUFA), the FDA has set a target date of October 5, 2018.
“OFF periods greatly disrupt the lives of people living with Parkinson’s, and there is a significant need for new treatments in this community,” said Burkhard Blank, M.D., Chief Medical Officer of Acorda. “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.
“People with Parkinson’s and physicians need more options to manage this disease,” said Todd Sherer, Ph.D., CEO of The Michael J. Fox Foundation. “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.
About Parkinson’s and OFF periods
Approximately one million people in the U.S. and 1.2 million Europeans are diagnosed with Parkinson’s; OFF periods are experienced by approximately 350,000 in the U.S. and 420,000 in Europe. Parkinson’s is a progressive neurodegenerative disorder resulting from the gradual loss of certain neurons responsible for producing dopamine. It causes a range of symptoms including impaired movement, muscle stiffness and tremors. As Parkinson’s progresses, people will experience OFF periods, which are characterized by the re-emergence of Parkinson’s symptoms. This re-emergence can occur even when an individual’s treatment regimen has been optimized.
About INBRIJA™ (CVT-301, levodopa inhalation powder) and ARCUS®
INBRIJA is a self-administered, orally inhaled levodopa (L-dopa) therapy in development for the treatment of symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa / levodopa regimen. INBRIJA utilizes Acorda’s investigational ARCUS® platform for inhaled therapeutics. INBRIJA was designed to deliver a precise dose of a dry powder formulation of L-dopa to the lung. Oral medication can be associated with variable onset of action, as the medicine is absorbed through the gastrointestinal (digestive) tract before reaching the brain. Inhaled treatments enter the body through the lungs and reach the brain, bypassing the digestive system.
The proprietary name INBRIJA has been conditionally accepted by the U.S. Food and Drug Administration (FDA).
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