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This program will include a discussion of off-label treatment and devices and investigational agents and devices not approved by the FDA for use in the.

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Presentation on theme: "This program will include a discussion of off-label treatment and devices and investigational agents and devices not approved by the FDA for use in the."— Presentation transcript:

1 Optimizing Outcomes in the Clinical Use of Intrathecal Analgesia for Chronic Pain

2 This program will include a discussion of off-label treatment and devices and investigational agents and devices not approved by the FDA for use in the United States and data that were presented in abstract form. These data should be considered preliminary until published in a peer-reviewed journal.

3 The Scope of Chronic Pain

4 Systemic Opioid Epidemic in the United States

5 Treatment Options for Chronic Pain

6 Treatment Options for Chronic Pain (cont)

7 Definition of and Indications for ITDD

8 Disease Indications for ITDD

9 Refractory Pain Defined

10 Comparing Systemically vs Intrathecally Delivered Opioids

11 IT Opioid Data for Up to 20+ Years

12 Daily Doses of IT Opioids at Mean of 11.77 Years

13 Complications and Interventions With Long-Term IT Opioid Therapy

14 NRS Scores Before and After Pump Implantation and at Time of Questionnaire

15 Percentage of Patients With AEs Associated With IT Opioid Therapy

16 AEs Associated With Long-Term IT Opioid Therapy

17 Satisfaction Among 36 Patients Receiving Long-Term IT Opioid Therapy

18 IT Delivery of Ziconotide for the Treatment of Chronic Pain

19 PRIZM Design

20 PRIZM Inclusion Criteria

21 PRIZM Outcomes

22 PRIZM Interim Results – Baseline Patient Information

23 Patients Receiving Ziconotide as First or Not First Agent in Pump in PRIZM

24 Mean % Change in NPRS Scores From Baseline in Patients Enrolled in PRIZM for ≥ 12 Months

25 Mean Percentage Change in NPRS Scores From Baseline in Entire PRIZM Population

26 Secondary Outcome of PRIZM PGIC

27 Continued Study Participation of Patients Receiving Ziconotide as First or Not First Agent in Pump in PRIZM

28 AEs Occurring in ≥ 5% of Patients in PRIZM

29 Serious AEs in PRIZM

30 Guidance for Patient Selection for ITDD The PACC

31 Patient Selection Criteria for ITDD for Chronic Pain

32 Patient Selection for ITDD

33 Patient Selection for ITDD for Noncancer Pain Equal Weight for Medical Devices and ITDD

34 Patient Selection for ITDD for Non-Cancer Pain Catheter Placement

35 Preimplantation Trial Is Standard of Care for ITDD

36 PACC Does Trialing Predict ITDD Outcome?

37 PACC Recommended Doses for IT Bolus Trialing

38 PACC Recommendations for Trialing Ziconotide

39 Chronic Infusion Strategies for ITDD

40 PACC: Recommended Starting Dose Ranges for of IT-Delivered Drugs for Long-Term Therapy

41 PACC: Maximum Concentrations and Daily Doses of IT Agents

42 PACC Recommendations Based on USPSTF Criteria

43 PACC Consensus Points

44 Conclusions

45 Abbreviations


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