Acorda Therapeutics announced the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) of Inbrija (levodopa inhalation powder) from October 5, 2018 to January 5, 2019.
This extension is related to recent submissions Acorda made in response to requests from FDA for additional information on chemistry, manufacturing and controls (CMC). FDA determined that these submissions constitute a major amendment and will take additional time to review.
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“We look forward to continuing our constructive dialogue with FDA,” said Ron Cohen, M.D., Acorda’s President and CEO. “We remain committed to bringing INBRIJA to approval for people with Parkinson’s who experience OFF periods, which are highly disruptive and in need of new therapeutic options.”
The FDA accepted Acorda’s NDA for Inbrija in February 2018.
Parkinson’s is a progressive neurodegenerative disorder resulting from the gradual loss of certain neurons responsible for producing dopamine. Approximately one million people in the U.S. and 1.2 million Europeans are diagnosed with Parkinson’s; it is estimated that approximately 40 percent of people with Parkinson’s experience OFF periods. 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 motor and non-motor symptoms. This re-emergence can occur even when an individual’s treatment regimen has been optimized.
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 through 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.