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# Acorda Therapeutics NDA for Parkinsons Therapy Planned for 2Q
- URL: https://www.fdaweb.com/acorda-therapeutics-nda-for-parkinsons-therapy-planned-for-2q/
- Published: 2017-02-09T12:00:00.000Z
- Updated: 2026-09-14T22:05:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137943

Acorda Therapeutics says it will file an NDA next quarter for Parkinson’s therapy CVT-301 after reporting Phase 3 clinical data that showed a statistically significant improvement in motor function in people with Parkinson’s disease experiencing motor fluctuations (OFF periods). CVT-301 is an investigational, inhalable formulation of levodopa being studied as a treatment for OFF periods in people with Parkinson’s disease taking an oral carbidopa/levodopa regimen. OFF periods refer to the re-emergence of Parkinson’s symptoms, according to the company.  
  
The safety profile of CVT-301 in the recent study was consistent with that observed in an earlier Phase 2b trial, Accorda says. “Spirometry and diffusing capacity of the lung for carbon monoxide (DLCO) tests showed no notable pulmonary safety signals,” it says. The company is currently conducting two studies to assess the therapy’s long-term safety profile, and up to 12-months of data from these studies are expected by the end of the quarter.