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Intracranial Pharmacotherapy and Pain Assays in Rodents
Published on: April 9, 2019
Intrathecal administration of Infumorph® vs compounded morphine for treatment of intractable pain using the Prometra®
Steven M Rosen1, Todd A Bromberg, Gurpreet Padda
1Fox Chase Pain Management Associates, Jenkintown, Pennsylvania 19046, USA. foxchasepain@aol.com
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.
Insights
Compounded morphine sulfate effectively treats chronic pain with comparable accuracy and safety to Infumorph. Higher doses of compounded morphine showed greater improvements in pain and disability.
Area of Science:
- Pain Management
- Pharmacology
- Neurosurgery
Background:
- Intrathecal morphine sulfate is an alternative to oral opiates for chronic pain.
- Infumorph is the only FDA-approved morphine sulfate for continuous intraspinal administration.
- Compounded morphine is used when patient needs exceed commercially available concentrations.
Purpose of the Study:
- To compare the accuracy, safety, and efficacy of Infumorph and compounded morphine sulfate.
- To evaluate performance in patients implanted with the Prometra programmable pump.
Main Methods:
- Collected accuracy, safety, and efficacy data from clinical trials.
- Compared results in 154 subjects implanted with the Prometra programmable pump.
- Analyzed data for subjects receiving Infumorph, compounded morphine, or both.
Main Results:
- Drug delivery accuracy was comparable: 100.1% for Infumorph and 97.4% for compounded morphine.
- Device-related serious adverse event (DRSAE) rates were similar between groups.
- Compounded morphine showed statistically significant improvements in pain and disability, while Infumorph improved only pain.
Conclusions:
- The Prometra system accurately delivers both Infumorph and compounded morphine.
- Compounded morphine effectively treats chronic pain patients.
- Higher doses of compounded morphine may offer better pain relief, balancing against granuloma risk.
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