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FDA Reviewing New Treatment for “Off” Episodes

Four beakers lined up on a table in a lab.

Another treatment option for patients who experience “off” time — periods when Parkinson’s symptoms return between medication doses — has reached an important milestone in possible approval. Earlier today, Sunovion Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application for apomorphine sublingual film. The FDA now will review the application, with a decision expected by May 21, 2020.

Apomorphine mimics dopamine, the brain chemical that decreases in Parkinson’s. Sunovion’s treatment delivers apomorphine in a thin, dissolvable strip (like a breath strip) that begins to work in as little as 10 minutes. It’s used in addition to (not as a replacement for) a person’s current drug regimen as an as-needed, on-demand therapy.

Todd Sherer, PhD, CEO of The Michael J. Fox Foundation for Parkinson’s Research (MJFF), says, “People with Parkinson's have shared that off episodes can be disruptive and hamper their quality of life. New treatments could mean greater symptom control for more people, improving their ability and confidence to navigate daily life with the disease.”

If approved, the sublingual film would provide another option for on-demand treatment of “off” time. Currently available therapies include Apokyn (injectable apomorphine) and Inbrija (an inhaled form of levodopa). MJFF funded early stage trials of both Inbrija and the apomorphine sublingual film.

It’s important to have multiple treatment options as patients may experience similar symptoms but respond differently to different medications or delivery methods. More options mean more people may find a treatment that works for them.

Learn more about sublingual apomorphine.

Read about “off” time.

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