FDA Approves Parkinson's Drug

The US Food and Drug Administration (FDA) today approved safinamide (Xadago/Newron Pharmaceuticals) as an add-on treatment for patients with Parkinson’s disease who experienced “off” episodes while already taking levodopa/carbidopa. Researchers described “off” episodes as a time when the patient’s medication stops working, increasing in tremors, difficulty walking, and other symptoms.

The neurological disorder usually occurs in people over age 60, but it can occur earlier, when cells in the brain that produce dopamine become impaired or die.

Safinamide’s approval followed a successful clinical trial of 645 participants who were also taking levodopa and were experiencing “off” periods.

Experts noted that compared to the placebo group, the patients who received safinamide experienced more beneficial “on” time — situations when Parkinson’s symptoms are reduced, without “troublesome” uncontrolled involuntary movement (dyskinesia. As a result, the increase in “on” time saw a reduction in “off” time as well as better scores on a measure of motor function.

Furthermore, a second clinical trial included 549 individuals who added safinamide to their levodopa prescription. These patients experienced more “on” time without “troublesome” uncontrolled involuntary movement compared to those taking a placebo, and also reported better scores on a measure of motor function assessed.

According to the results, the most commonly reported adverse reactions in patients taking safinamide were uncontrolled involuntary movement, falls, nausea, and trouble sleeping or falling asleep (insomnia). Researchers also noted that patients with severe liver conditions or those who take a medicine called a monoamine oxidase inhibitor (MAOI) because it may cause a sudden severe increase in blood pressure.