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# Parkinson’s NDA for Parkinson’s Accepted for Review
- URL: https://www.fdaweb.com/parkinsons-nda-for-parkinsons-accepted-for-review/
- Published: 2018-02-21T12:00:00.000Z
- Updated: 2026-09-14T23:24:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140805

FDA has accepted for review an Acorda Therapeutics NDA for Inbrija (inhaled levodopa) for treating symptoms of Off periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen. The agency has set a user fee review action target date of 10/5\. The submission 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, according to the company. Findings from these studies showed a statistically significant improvement in motor function in people with Parkinson’s experiencing Off periods, it says. As Parkinson’s progresses, people will experience Off periods, which are characterized by the re-emergence of Parkinson’s symptoms.