Original Research Article
Intrathecal Administration of Infumorph® vs Compounded Morphine for Treatment of Intractable Pain Using the Prometra® Programmable Pump
- This study was sponsored and funded by Flowonix Medical, Inc.. Mt Olive, NJ. Drs. Rosen and Deer have received fair market value compensation for serving on Flowonix Medical, Inc.'s scientific advisory board, as well as for serving as thought leaders for Flowonix Medical, Inc. initiatives. In addition, Dr. Rosen serves as a medical advisor to Flowonix Medical, Inc. and receives fair market value compensation.
Reprint requests to: Steven M. Rosen, MD, Fox Chase Pain Management Associates, 261 Old York Road, Suite 707, Jenkintown, PA 19046, USA. Tel: 215-722-7246; Fax: 856-983-9011; E-mail: firstname.lastname@example.org.
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.
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.
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.
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.