Introduction/Statement: We report a study to evaluate adverse events when adding Ziconotide to existing intrathecal pump patients receiving opioids with or without other adjuvants ( adjuvants include Clonidine,Bupivicaine,and Baclofen)who have existing implanted pumps.

Materials and methods: We are currently performing an open label case analysis of twenty patients receiving intrathecal Ziconotide plus intrathecal opioids. At several points during the analysis, data points are collected during an onsite clinic visit. Data collection includes visual analog scales (VAS), oral opioid use, physical/neurological exam and adverse events. Doses are initiated at 0.5 mcg/day and titrated every two weeks as needed.

Results: After 12 weeks there have been no reports of adverse events and all patients remain on drug therapy. Patients Ziconotide doses continue to be titrated up slowly with intrathecal opioid doses remaining the same or being decreased. In several patients, significant improvement has been seen in pain scores (3.0 VAS). There has not been any patients who has discontiniued the drug or reported any complications, side-effects or significant adverse events. No decreased oral opioid use has been reported at this time. Currently we are achieving reasonable therapeutic levels.

Conclusions: Intrathecal Ziconotide plus opioid therapy appear to show improvement in patients' pain levels. After 12 weeks we have seen that Zicontide is a safe additive to opioids for non cancer pain, when starting at a low dose and titrating up slowly. Monitoring safety of intrathecal Ziconotide plus opioid therapy will be continued throughout the duration of the case analysis.