Safinamide Receives FDA Approval for Treatment of Parkinson's Disease

The FDA granted approval to safinamide (Xadago) as an add-on treatment for patients with Parkinson’s disease who are taking levodopa/carbidopa and experiencing off episodes.

Off episodes are defined as a period when a patient’s medications are not working well, causing an increase in Parkinson’s symptoms, according to an FDA press release.

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

For the clinical trial, investigators sought to evaluate the efficacy of safinamide in 645 patients with Parkinson’s disease who were taking levodopa and experiencing “off” time. The results of the study showed that patients receiving safinamide experienced more beneficial “on” time—–when Parkinson’s symptoms were reduced––without dyskinesia, compared with patients who received the placebo.

The increase in “on” time was accompanied a reduction in “off” time. Furthermore, patients experienced an improvement in scores measuring motor function that was assessed during “on” time.

In a different clinical trial that included 549 participants, the patients who added safinamide to their levodopa treatment had more “on” time without troublesome uncontrolled involuntary movement compared with those taking a placebo. Patients also experienced better scores on a measure of motor function assessed during “on” time than before treatment, according to the release.

The most common adverse events (AEs) were uncontrolled involuntary movement, falls, nausea, and insomnia.

Serious AEs that were less common were hypertension; serotonin syndrome when used with monoamine oxidase inhibitors (MAOIs), antidepressants, or opioid drugs; falling asleep during activities of daily living; hallucinations and psychotic behavior; problems with impulse control/compulsive behaviors; withdrawal-emergent hyperpyrexia and confusion; and retinal pathology.

Patients should not take safinamide if they have severe liver problems or take dextromethorphan, MAOIs, opioids, St. John’s wort, certain antidepressants, or cyclobenzaprine.