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# NDA Accepted for Sunovion’s Parkinson’s Drug
- URL: https://www.fdaweb.com/nda-accepted-for-sunovions-parkinsons-drug/
- Published: 2018-06-13T12:00:00.000Z
- Updated: 2026-09-15T00:12:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141676

FDA has accepted for review a Sunovion NDA for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson’s disease. The agency has set a user fee review action target date of 1/29/2019.

The company says apomorphine sublingual film is being developed as a fast-acting medicine for the on-demand treatment of all types of motor OFF episodes, including morning OFF, unpredictable OFF and end-of-dose wearing OFF. The NDA is supported by data from two Michael J. Fox Foundation-funded trials of APL-130277 – a [comparative biostudy in healthy volunteers](http://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.michaeljfox.org%2Ffoundation%2Fgrant-detail.php%3Fgrant%5Fid%3D1019&esheet=51819724&newsitemid=20180612006068&lan=en-US&anchor=comparative+biostudy+in+healthy+volunteers&index=2&md5=b33cb115cdf74bb642cb8a61c6d911b4&ref=fdaweb.com) and a [dosing study in people with Parkinson's disease](http://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.michaeljfox.org%2Ffoundation%2Fgrant-detail.php%3Fgrant%5Fid%3D1343&esheet=51819724&newsitemid=20180612006068&lan=en-US&anchor=dosing+study+in+people+with+Parkinson%27s+disease&index=3&md5=54690281a1b80190ecdbdf2bfe7b291b&ref=fdaweb.com).