Acorda Therapeutics (ACOR) Announces Publication of CVT-301 Data in PD OFF Periods

October 13, 2016 7:09 AM EDT

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Results from Phase 1, Phase 2a and preclinical studies of CVT-301, an inhaled form of levodopa, have been featured in the current edition of Science Translational Medicine. Acorda Therapeutics, Inc. (NASDAQ: ACOR) is developing CVT-301 for the treatment of OFF periods in people with Parkinson’s disease (PD).

As PD progresses, people with Parkinson’s experience OFF periods, which are characterized by the re-emergence of PD symptoms. These include motor symptoms such as impaired movement, muscle stiffness, and tremor, as well as non-motor symptoms. This re-emergence can occur even when an individual’s treatment regimen has been optimized. OFF periods typically increase in frequency during the course of the disease.

“OFF periods can be hugely disruptive to the lives of people with Parkinson’s and their families, and are considered one of the greatest unmet medical needs in the treatment of Parkinson's,” said Ron Cohen, M.D., President and CEO of Acorda Therapeutics. “CVT-301 is an inhaled powder form of levodopa that is being studied in combination with standard of care Parkinson’s disease regimens. Following two successful Phase 2 clinical trials1 ,2, our Phase 3 program is assessing the extent to which CVT-301, used when people with Parkinson’s begin to experience OFF periods, can restore motor function. If approved, CVT-301 may provide a valuable new treatment option for these individuals.”

Acorda’s Phase 3 clinical program comprises a Phase 3 safety and efficacy study as well as general and special population safety studies. The program is designed to confirm the efficacy and safety profile of CVT-301 and support global regulatory marketing authorization applications. The Company expects to announce results from its randomized, placebo-controlled Phase 3 trial in Q1 2017.

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