Plans scrapped for Xadago trial for levodopa-induced dyskinesia

Newron Pharmaceuticals, Zambon Pharma announced joint plans in 2021

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Newron Pharmaceuticals and Zambon Pharma have ended their plans to run a clinical trial to test Xadago (safinamide) for uncontrolled movements induced by levodopa in people with Parkinson’s disease.

Xadago is widely approved as an add-on treatment to help manage Parkinson’s off episodes, or periods when symptoms are not adequately controlled between doses of levodopa-related treatments.

The announcement came as part of a corporate update from Newron, the therapy’s original developer, that noted that the companies “reached an agreement to discontinue their plans to initiate a clinical study with [Xadago] in Parkinson’s disease patients with levodopa-induced dyskinesia.”

The reasons for this decision have not been disclosed.

As part of the agreement, Zambon, which owns the rights to commercialize Xadago in most of the world, will provide an undisclosed fee to Newron. The therapy’s development and commercialization rights in certain parts of Asia are held by Meiji Seika, and in the U.S. by Supernus Pharmaceuticals.

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Xadago is an oral therapy that works through several mechanisms of action. It increases the brain’s levels of dopamine, the chemical messenger that’s progressively lost in Parkinson’s, by blocking the processes that normally break it down and those involved in its cellular uptake and retention.

The therapy also suppresses the excessive release of glutamate, another brain chemical messenger that’s thought to contribute to neurodegeneration in the disease.

According to Newron and Zambon, preclinical and clinical data suggested that, besides its ability to reduce off episodes, Xadago could help ease a common side effect of long-term levodopa — uncontrolled movements, or dyskinesia.

That prompted the announcement of joint plans in 2021 for a trial that would have tested Xadago for levodopa-induced dyskinesia. These plans have now been scrapped.

In its corporate update, Newron also noted that generic manufacturers have sought the approval of the U.S. Food and Drug Administration to sell generic formulations of safinamide, the active agent in Xadago.

Newron, Zambon, and Supernus are challenging these filings in court, noting that Newron holds patents that are expected to provide intellectual property protection for the therapy until at least 2027. These challenges are ongoing.