Xadago Clinical Efficacy

Two pivotal, 6-month studies—Study 1 (016) and Study 2 (settle)

In two randomized, 24-week, multicenter, double-blind, placebo-controlled trials, the efficacy and safety of XADAGO as add-on therapy to a stable dose of levodopa in PD patients experiencing motor fluctuations was evaluated.

Study 1 (016) and Study 2 (settle) efficacy outcomes

  • The primary endpoints were mean daily on time (on time without dyskinesia plus on time with non-troublesome dyskinesia) at 6 months
  • Secondary outcomes of Study 1 and Study 2 included:
    • Decrease in total daily off time, as measured by Hauser diary
    • UPDRS Part III during on phase – mean change from baseline to end of study
    • Parkinson’s Disease Questionnaire 39 (PDQ-39): mean change from baseline to end of study
  • In Study 2, if there were no tolerability issues by day 14, the starting dose was increased to 100 mg/day3

XADAGO 100 mg dose group showed significant improvements based on PDQ-39 score1-3


Study 018 was a double-blind, placebo-controlled, 18-month extension to Study 1 (016), aimed at assessing the long-term efficacy and safety of XADAGO as add-on therapy to levodopa in patients with PD and motor fluctuations.


  • The primary efficacy endpoint in Study 018 was the Dyskinesia Rating Scale (DRS) and was not statistically significant from placebo
  • Secondary outcomes of study 018 included:
    • Mean change from baseline to end of study in diary on time without troublesome dyskinesia
    • UPDRS Part III (motor) scores
    • Mean change from baseline to end of study in diary off time
  • Data from Study 018 do not appear in the XADAGO Prescribing Information
  • 66% of Study 016 patients completed the whole 2-year treatment period, and 81% of Study 018 patients completed the 18-month extension period
  • Changes and/or adjustments to subjects’ other concomitant PD medications were allowed throughout the study at the discretion of the site investigators

Xadago maintained daily on time without troublesome dyskinesia when used as an adjunct to levodopa1,6

  • The primary endpoint in Study 018 was the Dyskinesia Rating Scale (DRS) and was not statistically significant from placebo
  • Changes and/or adjustments to subjects’ other concomitant PD medications were allowed throughout the study at the discretion of the site investigators
  • 66% of Study 016 patients completed the whole 2-year treatment period, and 81% of Study 018 patients completed the 18-month extension period
  • Data from Study 018 do not appear in the XADAGO Prescribing Information

Reductions were seen in daily off time over 2 years when used as an adjunct to levodopa1,2,6

  • The primary endpoint in Study 018 was the Dyskinesia Rating Scale (DRS) and was not statistically significant from placebo
  • Changes and/or adjustments to subjects’ other concomitant PD medications were allowed throughout the study at the discretion of the site investigators
  • 66% of Study 016 patients completed the whole 2-year treatment period, and 81% of Study 018 patients completed the 18-month extension period
  • Data from Study 018 do not appear in the XADAGO Prescribing Information

XADAGO is generally well-tolerated7

Safety Profile

Patients with adverse reactions with an incidence ≥2% in the XADAGO 100 mg/day group and greater than placebo in studies 1 and 27

Overall discontinuation rates due to adverse reactions from Study 1 (016) and Study 2 (SETTLE) were 5% for XADAGO 50 mg/day, 6% for XADAGO 100 mg/day, and 4% for placebo7

Medical Inquiries and Reporting Adverse Events

  • For all medical inquiries, contact US WorldMeds Medical Affairs: 1-888-908-USWM (8796) or medinfo@usworldmeds.com. To report SUSPECTED ADVERSE REACTIONS or product complaints, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • You may also report SUSPECTED ADVERSE REACTIONS or product complaints to US WorldMeds at 1-888-4XADAGO (1-888-492-3246)
  • Additional information can be requested using the US WorldMeds Medical Information Request Form

Why XADAGO Now?

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References
  1. Borgohain R, Szasz J, Stanzione P, et al. Randomized trial of safinamide add-on to levodopa in Parkinson’s disease with motor fluctuations. Mov Disord. 2014;29(2):229-237.
  2. Data on file, US WorldMeds.
  3. Schapira AHV, Fox SH, Hauser RA, et al. Assessment of safety and efficacy of safinamide as a levodopa adjunct in patients with Parkinson disease and motor fluctuations: a randomized clinical trial. JAMA Neurol. 2017;74(2):216-224.
  4. Jenkinson C, Fitzpatrick R, Peto V, et al. The Parkinson's Disease Questionnaire (PDQ-39): development and validation of a Parkinson's disease summary index score. Age Ageing. 1997;26: 353-357.
  5. Goetz CG, Tilley BC, Shaftman SR, et al. Movement Disorder Society-sponsored revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008;23(15) 2129-2170.
  6. Borgohain R, Szasz J, Stanzione P, et al. Randomized trial of Safinamide add-on to levodopa in Parkinson’s disease with motor fluctuations. Mov Disord. 2014;29(10):1273-1280.
  7. XADAGO® (safinamide) [Prescribing Information]. Louisville, KY: US WorldMeds, LLC; 2017.