A Randomized, Double-Blind, Placebo-Controlled Study of Intrathecal Ziconotide in Adults with Severe Chronic Pain Richard L. Rauck, MD, Mark S. Wallace,

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A Randomized, Double-Blind, Placebo-Controlled Study of Intrathecal Ziconotide in Adults with Severe Chronic Pain Richard L. Rauck, MD, Mark S. Wallace, MD, Michael S. Leong, MD, Michael MineHart, MD, Lynn R. Webster, MD, Steven G. Charapata, MD, Jacob E. Abraham, MD, Daniel E. Buffington, PharmD, MBA, David Ellis, MD, PhD, Ronald Kartzinel, MD, PhD, the Ziconotide 301 Study Group Journal of Pain and Symptom Management Volume 31, Issue 5, Pages 393-406 (May 2006) DOI: 10.1016/j.jpainsymman.2005.10.003 Copyright © 2006 U.S. Cancer Pain Relief Committee Terms and Conditions

Fig. 1 Patient disposition and termination by treatment group. a44 patients did not require weaning of IT medications and entered the stabilization period directly. (Of the 44 patients who did not enter weaning, 23 had their pump implanted less than a month before the study; one, 3 months before consent; and the other 20 had their pumps for greater than 200 days. Of these 44 patients, three were on low-dose opioid monotherapy and the other 41 had no IT drugs at screening). b184 patients completed the weaning period and entered the stabilization period. Journal of Pain and Symptom Management 2006 31, 393-406DOI: (10.1016/j.jpainsymman.2005.10.003) Copyright © 2006 U.S. Cancer Pain Relief Committee Terms and Conditions

Fig. 2 Mean percentage change in VASPI score from baseline to Weeks 1, 2, and 3 using the LOCF imputation method. The primary efficacy outcome was the mean percentage change in VASPI score from baseline to Week 3. Baseline VASPI score was 80.7 (SD 15). Journal of Pain and Symptom Management 2006 31, 393-406DOI: (10.1016/j.jpainsymman.2005.10.003) Copyright © 2006 U.S. Cancer Pain Relief Committee Terms and Conditions

Fig. 3 (a) and (b). CGI at termination. For satisfaction with therapy (a) and Overall Pain Control (b), the difference between the two treatment groups was statistically significant (P=0.0027 and P=0.0004, respectively; Mantel-Haenszel Chi-squared test with one degree of freedom, assuming equally spaced scores). Journal of Pain and Symptom Management 2006 31, 393-406DOI: (10.1016/j.jpainsymman.2005.10.003) Copyright © 2006 U.S. Cancer Pain Relief Committee Terms and Conditions