XADAGO  fishing

Why Xadago now?

Levodopa initially provides consistent therapeutic effect on motor symptoms of PD - and is particularly effective in providing symptomatic relief of rigidity and bradykinesia.1

Despite its efficacy, levodopa’s therapeutic window narrows over time2,3

90% Of the 1 million people living with pd in the US

ARE USING LEVODOPA1,4


Chronic use of levodopa is associated with complications2


Pulsatile stimulation of postsynaptic receptors by levodopa may lead to alterations in striatal output that promotes levodopa-induced dyskinesia (LID)5

High levodopa dose (>400 mg/day) may increase risk of developing LID7

Heterogeneity in Levodopa response increases the need for adjunctive treatment options8

Xadago Clinical Efficacy

Two pivotal 6-month studies—Study 1 (016) and Study 2 (settle)9,10

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.11

Study 1 (016) and Study 2 (settle) efficacy outcomes9,10,12:

  • 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/day10

Key inclusion criteria:

Male or female, 30–80 years with a diagnosis of idiopathic PD of >3 years’ duration. Patients may be receiving concomitant treatment with stable doses of a dopamine agonist and/or an anticholinergic and/or amantadine. Motor fluctuations with >1.5 hours off time during day


Key exclusion criteria:

Dementia, major psychiatric illnesses, progressive medical illnesses, SNRIs and opioids

XADAGO 100 mg dose significantly improved Parkinson's Disease Questionnaire-39 (PDQ-39) scores9,10,12

  • There were no statistically significant differences between Xadago 50 mg and placebo

PDQ-39 is a PD-specific health status questionnaire comprised of 39 items. Items are grouped into eight subscales (mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, bodily discomfort) that are scored by expressing summed item scores as a percentage score ranging between 0 and 100.14


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
    • Mean change from baseline to end of study in diary off time
    • UPDRS Part III (motor) scores
  • 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 levodopa9,15

ON AVERAGE, PATIENT POPULATION HAD PD 8 YEARS AT BASELINE9,15

  • 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 levodopa 9,12,15

Consider adding Xadago to patients on levodopa who are experiencing motor fluctuations

  • 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

Improvements in motor function as assessed by UPDRS III with the 100 mg dose9,12,15

  • There were no statistically significant differences between XADAGO 50 mg and placebo.
  • 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.

≥ 2% XADAGO 100 mg/day group and greater than placebo in Studies 1 and 211

  • Incidence of patients discontinuing from Study 1 (016) and 2 (SETTLE)11
    • XADAGO 50 mg/day 5%
    • XADAGO 100 mg/day 6%
    • Placebo 4%
  • Most common adverse event causing study discontinuation was dyskinesia11
    • XADAGO 50 mg/day 1%
    • XADAGO 100 mg/day 1%
    • Placebo 0%


>87% of patients in clinical trials required no decrease in their stable levodopa dose9,10

NEXT: Identifying patients for treatment with XADAGO


See who could benefit from XADAGO

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Find out how XADAGO is dosed

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References
  1. Olanow CW, Stern MB, Sethi K. The scientific and clinical basis for the treatment of Parkinson’s disease (2009). Neurology. 2009;72(Suppl 4):S1-S136.
  2. Hickey P, Stacy M. Available and emerging treatments for Parkinson’s disease: a review. Drug Des Devel Ther. 2011:241-254.
  3. Jankovic J. Motor fluctuations and dyskinesias in Parkinson’s disease: clinical manifestations Mov Disord.2005;20(11):S11-S16.
  4. Tambasco N, Simoni S, Marsili E, et al. Clinical aspects and management of levodopa-Induced dyskinesia. Parkinson’s Disease. Volume 2012;Article ID 745947:1-12.
  5. Thanvi B, Lo N, Robinson T. Levodopa-induced dyskinesia in Parkinson’s disease: clinical features, pathogenesis, prevention and treatment. Postgrad Med J. 2007;83:384-388.
  6. DeMaagd G, Philip A. Parkinson’s disease and its management. Part 4: Treatment of motor complications. P&T.2015;40(11):747-773.
  7. Olanow CW, Kieburtz K, Rascal O, et al. Factors Predictive of the Development of Levodopa-Induced Dyskinesia and Wearing-Off in Parkinson’s Disease. Mov Disord. 2013;28:1064-1071.
  8. Lewis S J G, Foltynie T, Blackwell AD, et al. Heterogeneity of Parkinson’s disease inthe early clinical stages using a data driven approach. J Neurol Neurosurg Psychiatry. 2005;76:343–348.
  9. 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.
  10. 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. 2016;E1-E9.
  11. XADAGO Full Prescribing Information. May 2017.
  12. Data on file, US WorldMeds.
  13. 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. Movement Disord. 2008; 23(15) 2129-2170.
  14. 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.
  15. 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.