Newron, along with Zambon S.p.A and US WorldMeds, announced that the Food and Drug Administration (FDA) has approved Xadago (safinamide) for the treatment of Parkinson’s disease as add-on therapy to levodopa/carbidopa.
The approval of Xadago, a selective MAO-B inhibitor, marks the first new chemical entity to be approved for Parkinson’s disease in over 10 years. Xadago was evaluated in two double-blind, placebo-controlled, multinational, 6-month studies with >1,100 patients. Data showed Xadago statistically and significantly increased “on” time without troublesome dyskinesia as well as a reduced “off” time.
Newron’s CMO, Ravi Anand, added, “International, randomized, clinical trials have demonstrated that Xadago significantly improves ON time, OFF time, and Parkinsonism compared to standard of care without increasing time spent with troublesome dyskinesia in patients experiencing motor fluctuations while on optimized levodopa/carbidopa therapy. Additionally, the onset of improvement of motor fluctuations occurred early in treatment.”
The most common adverse reactions seen in patients taking Xadago were uncontrolled involuntary movement, falls, nausea, and insomnia.
In the U.S., Xadago will be developed and commercialized by US WorldMeds.
For more information call (888) 492-3246 or visit USworldmeds.com.