FDA approves new Parkinson’s drug

The U.S. Food and Drug Administration has approved a new medication to help people with Parkinson’s disease.

The FDA granted Newron Pharmaceuticals approval for Xadago (safinamide) tablets, an add-on treatment for people with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes.  An “off” episode is when a person’s medications are not working well, which causes an increase in Parkinson’s symptoms.

“Parkinson’s is a relentless disease without a cure,” said Eric Bastings, MD, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “We are committed to helping make additional treatments for Parkinson’s disease available to patients.”

In two separate clinical trials, Xadago was shown to increase more beneficial “on” time, a period when Parkinson’s symptoms are reduced, without uncontrolled involuntary movement, dyskinesia; reduced “off” time; and better motor functioning assessment scores than before treatment.


Topics: Alzheimer's/Dementia , Clinical