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      For levodopa-responsive patients with Complex/Advanced Parkinson's disease

      Consider DUODOPA when available combinations of Parkinson medicinal products have not given satisfactory results

      What DUODOPA may be able to offer your
      Complex/Advanced patients

      A different method of administration1

      DUODOPA's continuous intestinal administration avoids issues related to delayed gastric emptying, enabling consistent delivery with rapid absorption1-4

      Smooth and consistent levodopa delivery3,5-7

      Treatment strategies that provide a continuous flow of dopamine, and can thus mimic normal physiological dopamine stimulation, have potential to improve control of people with Complex/Advanced PD3,7

      Individualised delivery1

      Dosing is individually optimised to suit the patient over a 16-hour period, but can be provided up to 24 hours a day if medically justified1,3,7

      Why is continuous dopaminergic stimulation, which can be an alternative to pulsatile, non-continuous stimulation, important?3,5-7

      Over time, progressive neurodegeneration and the chronic use of oral dopaminergic therapy, such as levodopa, cause intermittent stimulation of dopamine receptors in the brain, which may lead to treatment-resistant motor complications5,6

      Continuous infusion of DUODOPA can provide a smooth and consistent delivery of levodopa8

      In a multicentre, multiple-dose, open-label study of 19 subjects with Complex/Advanced PD receiving DUODOPA over 30 days:8

      • DUODOPA rapidly achieved therapeutic plasma levels of levodopa8
      • DUODOPA maintained stable plasma levodopa levels over 16 hours8
      • DUODOPA's continuous intestinal delivery allows rapid absorption, avoiding fluctuations in drug delivery that result from erratic gastric emptying1,8

      Adapted from Nyholm D et al. 2013.

      PD=Parkinson's disease; SD=standard deviation.

      Motor symptoms

      In a study, DUODOPA provided predictability of 'ON' time and 'OFF' time9

      A 54-week, international, prospective, open-label study assessed the safety and efficacy of DUODOPA in Complex/Advanced PD patients with severe motor fluctuations (N=354). Safety was the primary endpoint; for the majority of patients AEs were mild or moderate and transient. Secondary endpoints included 'OFF' time, 'ON' time with/without troublesome dyskinesia, UPDRS and HRQoL outcomes.9

      Complex/Advanced patients with severe motor fluctuations on DUODOPA had a significant increase in 'ON' time without troublesome dyskinesia and a significant decrease in 'OFF' time compared with baseline (both p<0.001), which was sustained throughout the study.9

      Adapted from Fernandez HH et al. 2015.

      AE=adverse event; HRQoL=health-related quality of life; PD=Parkinson's disease; UPDRS=Unified Parkinson's Disease Rating Scale.

      DUODOPA has demonstrated benefits in both motor and associated non-motor symptoms9-11

      In a study, benefits in non-motor symptoms were sustained over a period of two years with DUODOPA10

      The GLORIA registry: A 24-month, non-interventional, observational registry study, evaluating the long-term efficacy of DUODOPA on motor and non-motor symptoms, QoL and safety in Complex/Advanced PD patients (N=375).10

      Significant and sustained improvements in motor fluctuations and some associated non-motor symptoms were observed, particularly in:10*

      • Sleep/fatigue (p<0.001)10
      • Mood/cognition (p=0.004)10
      • Gastrointestinal symptoms (p<0.001)10

      Adapted from Antonini A et al. 2017.

      *Improvement measured by reduction from baseline in the mean non-motor symptoms scale (NMSS) scores.
      GI=gastrointestinal; NMSS=non-motor symptoms scale; PD=Parkinson's disease; QoL=quality of life.

      Safety and tolerability9,10

      A generally well-understood safety profile with years of experience9,10

      • Levodopa therapy has been used in clinical practice for over 40 years and has an established and well-understood safety profile1,12
      • DUODOPA can provide continuous infusion of levodopa, the gold standard treatment, for levodopa-responsive Parkinson's disease in Complex/Advanced patients1,4,13
      • A safety analysis was performed for patients who received DUODOPA in all studies, to allow for a summary of the drug-related adverse reactions1,9,14

      Drug-related undesirable effects that occur frequently with the DUODOPA system:1

      *Adverse drug reactions observed in clinical trials. Frequencies assigned reflect adverse event frequencies and are regardless of causality assigned by the investigator.1

      Impulse control disorders: pathological gambling, increased libido and hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa including DUODOPA.1


      • Another analysis was performed for patients who received DUODOPA or placebo gel via PEG-J to allow for a summary of procedure- and device-related adverse reactions in all studies1,9,14

      Device- and procedure-related undesirable effects that occur frequently with the DUODOPA system include:1

      *Adverse drug reactions observed in clinical trials. Frequencies assigned reflect adverse event frequencies and are regardless of causality assigned by the investigator.1

      Complication of device insertion was a commonly reported adverse reaction for both the nasojejunal tube and the PEG-J. This adverse reaction was co-reported with 1 or more of the following adverse reactions for the nasojejunal tube: oropharyngeal pain, abdominal distention, abdominal pain, abdominal discomfort, pain, throat irritation, gastrointestinal injury, esophageal haemorrhage, anxiety, dysphagia, and vomiting. For the PEG-J, this adverse reaction was co-reported with 1 or more of the following adverse reactions: abdominal pain, abdominal discomfort, abdominal distension, flatulence, or pneumoperitoneum. Other non-serious adverse reactions that were co-reported with complication of device insertion included abdominal discomfort, abdominal pain upper, duodenal ulcer, duodenal ulcer haemorrhage, erosive duodenitis, gastritis erosive, gastrointestinal haemorrhage, peritonitis, pneumoperitoneum, small intestine ulcer.1

      PEG-J=percutaneous endoscopic gastro-jejunostomy


      • Most device and procedure related adverse reactions to DUODOPA occurred during the first 28 days after the PEG-J procedure1,9,14
      • Serious side effects include: Anaphylactic reaction, leucopenia, thrombocytopenia, agranulocytosis, neuroleptic malignant syndrome, eye disorders, gastrointestinal bleeding and duodenal ulceration, malignant melanoma, and sepsis1

      DUODOPA has a generally well-understood safety profile9

      A 54-week, international, prospective, open-label study assessed the safety and efficacy of DUODOPA in Complex/Advanced PD patients with severe motor fluctuations (N=354).9

      324 (91.5%) of the 354 enrolled patients completed the NJ phase and proceeded to PEG-J.9

      Adapted from Fernandez HH et al. 2015.

      *A single event could be coded to >1 preferred term.
      AE=adverse event; NJ=nasojejunal; PEG-J=percutaneous endoscopic gastro-jejunostomy.

      • For the majority of patients adverse events were mild (18.5%) or moderate (43.8%) and transient9
      • Low withdrawal rate (7.6%) due to adverse events, most commonly due to complication of insertion of device9

      For more detailed safety information, please refer to the Summary of Product Characteristics (SmPC).

      References

      1. DUODOPA (levodopa/carbidopa intestinal gel) Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/medicine/20786. Accessed August 2022.
      2. Burack M, et al. Mov Disord Clin Pract 2018;5:383-93.
      3. Antonini A. J Mov Disord 2009;2:4-9.
      4. Slevin JT, et al. J Parkinsons Dis 2015;5:165-74
      5. Olanow CW, et al. Nat Clin Pract Neurol 2006;2(7):382-92.
      6. Thanvi BR and Lo TCN. Postgrad Med J 2004;80:452-8.
      7. Nyholm D. Parkinsonism Relat Disord 2007;13:S13-7.
      8. Nyholm D, et al. AAPS J 2013;15:316–23.
      9. Fernandez HH, et al. Mov Disord 2015;30(4):500–9.
      10. Antonini A, et al. Parkinsonism Relat Disord 2017;45:13–20 and Supplementary Data.
      11. Antonini A, et al. Neurodegener Dis Manag 2018;8:161-70.
      12. Poewe W, et al. Clin Interv Aging 2010;5:229-38.
      13. Boyd JT, et al. Clin Park Relat Disord 2020;2:25-34.
      14. Olanow, et al. Lancet Neurol. 2014;13:141-9.

       

       

       

       

      Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk.

      Adverse events should also be reported to AbbVie on GBPV@abbvie.com 

       

       UK-DUOD-210223. Date of preparation: August 2022.