- First and Only FDA-Approved Inhaled Levodopa for Intermittent Treatment of OFF Episodes in People with
Parkinson’s Taking Carbidopa/Levodopa - Expected to be Available by Prescription in First Quarter 2019
- Based on Innovative ARCUS® Technology Platform for Inhaled Drug Delivery
- Conference Call on Monday, December 24, 2018 at 8:30am Eastern Time
ARDSLEY, N.Y.–
(BUSINESS WIRE)– Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that the U.S. Food
and Drug Administration approved INBRIJA™ for intermittent treatment of OFF episodes in people with Parkinson’s
disease treated with carbidopa/levodopa. OFF episodes, also known as OFF periods, are defined as the return of
Parkinson’s symptoms that result from low levels of dopamine between doses of oral carbidopa/levodopa, the
standard oral baseline Parkinson’s treatment.
“Today’s approval of INBRIJA marks a major milestone for both Acorda and the Parkinson’s community, for whom
we are gratified to have developed this much needed therapy,” said Ron Cohen, M.D., Acorda President and CEO.
“This milestone resulted from over two decades of research and development, beginning in the laboratory of Dr.
Robert Langer at Massachusetts Institute of Technology, through years of enormous perseverance and ingenuity by
the entire Acorda team.”
“Despite being on treatment, patients may experience OFF periods as Parkinson’s progresses, which can be
disruptive,” said Todd Sherer, Ph.D., CEO, The Michael J. Fox Foundation. “The Foundation provided funding for the
early clinical development of INBRIJA because patients told us that OFF periods were one of their most serious
issues. We knew we had to help address this unmet need, and this approval is a significant step forward for the
community as it provides a new option to manage these gaps in symptom control.”
“In the clinical study program, INBRIJA established its safety prole and demonstrated clinically meaningful improvements in motor function, as measured by the UPDRS Part III,” said Robert A. Hauser, M.D., MBA, Professor of Neurology and Director of the Parkinson’s Disease and Movement Disorders Center at the University of South Florida. “INBRIJA helps address a significant unmet need for people with Parkinson’s, and we look forward to adding this new treatment option to our armamentarium.”
FDA approval of INBRIJA was based on a clinical program —
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