• linkedin
  • Increase Font
  • Sharebar

    Safinamide (Xadago): Approved as Add-On for Parkinson’s


    Parkinson’s disease affects an estimated one million Americans: 50,000 new cases are diagnosed annually.1 This disorder is characterized by tremors and difficulty ambulating due to decreased production of dopamine, which helps transmit signals that produce purposeful movements. Dopamine replacement therapies, such as levodopa, are the mainstay of treatment. As the disease progresses, patients experience “off” episodes during which symptoms worsen, and “on” times when symptoms are reduced without troublesome dyskinesia.

    The FDA approved safinamide (Xadago) by Newron Pharmaceuticals in March 2017 as an add-on treatment for patients taking levodopa/carbidopa who experience “off” episodes.1 Safinamide is a monoamine oxidase (MAO) B inhibitor: it decreases the breakdown of dopamine and leads to increased dopamine levels and subsequently increased dopaminergic activity.2 Safinamide has greater selectivity for MAO-B versus MAO-A than selegiline and rasagiline.3

    The effectiveness of safinamide was demonstrated in two randomized clinical trials in patients who were also taking levodopa and experiencing “off” episodes. In the first trial, 645 patients were randomized to safinamide 50 mg, safinamide 100 mg, or placebo for up to 24 weeks.4 The “on” time was significantly increased for safinamide 50 mg and 100 mg compared to placebo.4 The effect of safinamide 100 mg was numerically greater than safinamide 50 mg, but no statistical comparison was completed. Improvements in “on” time were not associated with any increases in dyskinesia.4

    In the second trial, 549 patients were randomized to safinamide 100 mg daily or placebo for up to 24 weeks.5 This trial demonstrated an effect similar to that seen in the previous trial: there was significantly increased “on” time for safinamide 100 mg relative to placebo.5 Patients in the safinamide group also had less “off” time and improved motor function during “on” time.5

    Adam S. Whalley, PharmD
    Adam S. Whalley, PharmD is a PGY-1 pharmacy resident at UConn John Dempsey Hospital at UConn Health, Farmington, CT
    Kevin W. Chamberlin, PharmD
    Kevin W. Chamberlin, PharmD, is associate clinical professor and assistant department head, pharmacy practice, University of Connecticut ...


    You must be signed in to leave a comment. Registering is fast and free!

    All comments must follow the ModernMedicine Network community rules and terms of use, and will be moderated. ModernMedicine reserves the right to use the comments we receive, in whole or in part,in any medium. See also the Terms of Use, Privacy Policy and Community FAQ.

    • No comments available
    10 Old Remedies You Wont Find on Pharmacy Shelves Today
    10 Old Remedies You Wont Find on ...

    Not too long ago, it seemed like anything could end up in a pharmacy—with disastrous (or sometimes just humorous) results.

    2018 Novel Drug Approvals: The First ...
    Five Tips for Surviving a 12-Hour ...
    The Top 5 Pharmacist Movies of All Time