FDA Approves Add-On Drug for Parkinson's Disease

The FDA has approved Newron Pharmaceutical’s Xadago (safinamide), an add-on treatment for patients with Parkinson’s disease. The drug is indicated as an additional treatment for individuals who are already taking levodopa/carbidopa, and who are experiencing “off” episodes where the medication is not working effectively.

Patients who are experiencing “off” episodes that contribute to an increase in Parkinson’s symptoms, such as tremors and difficulty walking, will benefit from Xadago. Xadago’s approval is based on 2 clinical trials. In 1 trial of 645 participants, those who took Xadago experienced more beneficial “on” time, a time when symptoms are reduced. Participants also experienced reduced “off” episodes and better scores on a measure of motor function assessed during “on” time than before treatment.

In another trial, participants who took Xadago in addition to their levodopa treatment experienced more “on” time without uncontrollable involuntary movements compared to those taking a placebo. They also had improved assessment scores on motor function than before treatment.

The most common adverse effects observed included uncontrolled involuntary movements, falls, nausea, and trouble sleeping or falling asleep.

Reference

FDA approves drug to treat Parkinson’s disease [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm547852.htm. Accessed Mar. 21, 2017.