Trial of Xadago in Treating Levodopa-induced Dyskinesia Planned
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.
Xadago was first approved to treat “off” episodes in the European Union in 2015. Since then, it has been approved for this purpose in the U.S., as well as in Canada, Australia, Switzerland, the United Kingdom, Latin America, Israel, the United Arab Emirates, Japan, and South Korea.
“Since 2015, thousands of Parkinson’s disease patients around the world have benefited from safinamide’s safe and efficacious profile and the subsequent improvement in their motor fluctuations,” Castellani said.
Evidence in preclinical and clinical studies also indicate that it might ease dyskinesia, said Ravi Anand, the chief medical officer of Newron.
“We will be working with international clinical experts and regulatory authorities to finalize the design of a global trial to demonstrate the benefits of safinamide on dyskinesia in patients with [Parkinson’s],” Anand said.
Zambon owns the rights to develop and commercialize Xadago globally, excluding Japan and certain other Asian territories, where Meiji Seika has the rights to develop and commercialize the therapy. In the U.S., development and commercialization rights have been acquired by Supernus Pharmaceuticals.
“We welcome the agreement reached between our partners and look forward to the next steps towards the initiation of the study,” said Jonathan Rubin, chief medical officer at Supernus. “Supernus recognizes the substantial potential benefits a label extension covering [levodopa-induced dyskinesia], if approved by the FDA [U.S. Food and Drug Administration], would offer to the patients.”