Intrathecal administration of Infumorph® vs compounded morphine for treatment of intractable pain using the Prometra® programmable pump.

OBJECTIVES: The intrathecal administration of morphine sulfate has become an established alternative to oral opiate therapy for the treatment of chronic pain. Currently, Infumorph(®) is the only morphine sulfate approved by the US Food and Drug Administration for continuous intraspinal administration with an infusion pump. However, in order to achieve and maintain adequate pain relief, patients may require concentrations outside of those commercially available products resulting in the use of compounded morphine. METHODS: Accuracy, safety, and efficacy data related to Infumorph and compounded morphine use were collected during clinical trials of a new implantable pump. This report compares those results in a total of 154 subjects implanted with the Prometra programmable pump. RESULTS: The mean drug delivery accuracy using only Infumorph in 31 subjects was 100.1% and was comparable with the accuracy reported for the 71 subjects who received only compounded morphine sulfate (97.4%). The percentage of subjects free from device-related serious adverse events (DRSAEs) was similar in both groups. Compounded morphine showed statistically significant improvements in pain and disability, where Infumorph only showed a statistical improvement in pain. Dosing was higher in the compounded group. Results are also presented for a crossover group that received both types of morphine. CONCLUSIONS: ThePrometra system accurately delivers both Infumorph and compounded morphine with no significant differences in DRSAE rates. These results indicate that compounded morphine delivery effectively treats the chronic pain patient population. Higher doses appear to provide better pain relief; however, optimal pain relief will need to be balanced against the risk of granuloma formation.

Long-term follow-up of a novel implantable programmable infusion pump.

OBJECTIVES: The Prometra® Programmable Pump System (Flowonix Medical, Inc., Mt. Olive, NJ, USA) is designed for continuous intrathecal administration of morphine sulfate to treat chronic intractable pain. As a follow-up to a previous report on acute six-month data, this study evaluated the efficacy of treatment at one year and the accuracy of drug delivery throughout the study (average of 2.5 years, range 0-3.6 years). METHODS: Accuracy of drug delivery was determined as the ratio of delivered-to-programmed drug volume at scheduled refill visits (monthly for the first six months and every three months thereafter). Efficacy was assessed at 12 months using the visual analog and numeric rating scales and the Oswestry Disability Index. Safety was assessed by documenting adverse events and device complications throughout the study. RESULTS: The mean accuracy of the Prometra pump was 97.9% and was comparable to the reported accuracy at one to six months (97.1%). After 12 months, 68% of the remaining subjects reported improvement in disability scores from baseline and more than 75% of the remaining subjects reported decreases in pain from baseline. The incidence rates of adverse events and device complications were similar to previous reports for this therapy. CONCLUSIONS: The Prometra pump demonstrated accurate drug delivery throughout the study and provides an effective and safe means for intrathecal administration of morphine sulfate for treatment of chronic intractable pain.

Accuracy and efficacy of intrathecal administration of morphine sulfate for treatment of intractable pain using the Prometra(®) Programmable Pump.

OBJECTIVES: Intrathecal infusion pumps are increasingly used to deliver analgesics for chronic intractable pain. This trial evaluated the accuracy and efficacy of the new Prometra® Programmable Pump System for intrathecal administration of morphine sulfate to treat chronic intractable pain. METHODS: One hundred and ten patients were given continuous intrathecal morphine sulfate and assessed monthly for up to six months. Accuracy was determined as the ratio of delivered to programmed drug volume (DP ratio). Efficacy was assessed using the visual analog and numeric rating scales and the Oswestry Disability Index. RESULTS: The mean accuracy of the Prometra pump was 97.1%, with a 90% confidence interval of 96.2-98.0%. Decreases in pain and disability were reported at 68.4% of patient visits. No unanticipated adverse events or device complications were reported. CONCLUSIONS: The Prometra pump provides an accurate, effective, and safe system for intrathecal administration of morphine sulfate for treatment of chronic intractable pain.