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- 03/22/2017

U.S. regulators have approved the first new drug in a decade for Parkinson’s disease

Pharma Horizon

The FDA has approved safinamide tablets (Xadago, Newron Pharmaceuticals) for treatment of Parkinson’s disease as add-on therapy, when a patient’s regular medicines aren’t working well.

The pill was tested in two six-month studies: first in a clinical trial of 645 patients with Parkinson’s disease who were experiencing “off” time while taking levodopa, those who added safinamide experienced more “on” time than did those who added placebo. In the second clinical trial of 549 patients, those adding safinamide to their levodopa treatment had more “on” time without troublesome uncontrolled involuntary movement compared with those who added placebo.

Levodopa, which most patients take, can become less effective as the disease progresses, that’s why additional medicines are then needed

Milan, Italy-based Newron Pharmaceuticals has developed Xadago, ans has been approved in the European Union in 2015.

The drug will be market in U.S. by Meds LLC, Kentucky with a list price without insurance of  $670 for a 30-day supply of either the 50- or 100-milligram dose.

Source: The Washington Times, FDA statement




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