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New “Off” Medication Submitted to FDA

Female researcher in lab with tool.

There is good news for people with Parkinson’s who experience “off” time – periods when symptoms return between medication doses. Under-the-tongue apomorphine, a new treatment option for “off” episodes, is one step closer to being available to patients.

Sunovion Pharmaceuticals Inc. today announced the resubmission of a New Drug Application – a formal proposal asking for approval – to the U.S. Food and Drug Administration (FDA). The FDA now will determine whether it has all information necessary to fully review the drug and decide on approval.  

Apomorphine mimics dopamine, the brain chemical that decreases in Parkinson’s. When administered through a dissolvable, thin-film strip (like a breath freshener), apomorphine can rapidly reverse symptoms. In trials (Phase I and II funded by The Michael J. Fox Foundation), the drug worked in as little as 10 minutes in some people. Under-the-tongue apomorphine is meant to be added to a person’s current drug regimen and taken as needed for “off” time that occurs unexpectedly or between medication doses.

If approved, this therapy would expand available on-demand options for quickly reversing “off” times, including an apomorphine injection (Apokyn) and the recently approved (and MJFF-funded) inhaled levodopa (Inbrija). More options mean more potential benefits, since people, their Parkinson’s and their medication responses can vary.

Learn more about sublingual apomorphine.

Read about “off” time.

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