Newron Pharmaceuticals and Zambon Pharma agreed to jointly support a potentially pivotal clinical trial of Xadago (safinamide) as a treatment of levodopa-induced dyskinesia in people with Parkinson’s disease.
Under the terms of the agreement, Newron and Zambon will evenly share the cost of the intended study. Newron, which developed the therapy, will sponsor the trial and be responsible for its development and execution; it also will take the lead in working with regulators.
Positive results could support a label extension for Xadago, pending regulatory approval.
“We look forward to working closely with Newron to potentially provide a new treatment option for those living with [levodopa-induced dyskinesia], an area of huge medical need,” Paola Castellani, chief medical officer and R&D head of Zambon, said in a press release.
Parkinson’s disease is caused by loss of dopamine-producing cells in the brain. Treatments like levodopa, which aim to increase dopamine levels, are part of patients’ standard care. While these treatments can substantially ease Parkinson’s symptoms, their long-term use is associated with a risk of dyskinesia (uncontrolled and involuntary muscle movements).
Xadago is an oral, once-daily medication that is used to treat “off” episodes, period when other Parkinson’s medications stop providing a benefit. The therapy works through several mechanisms of action, including blocking the processes that normally degrade dopamine in the brain, and blocking the excessive release of a brain signaling molecule called glutamate.