About the Therapy Targeted Drug Delivery

LESS PAIN. FEWER SIDE EFFECTS.

Medtronic Targeted Drug Delivery (also known as intrathecal drug delivery) uses the SynchroMedTM II infusion system to manage chronic pain, including intractable cancer pain. Unlike oral medications that must be absorbed systemically and cross the blood-brain barrier to reach pain signals, targeted drug delivery interrupts pain pathways at their source in the cerebrospinal fluid and spinal cord. An implanted, programmable pump and catheter release prescribed amounts of pain medication directly into the intrathecal space.

Targeted Drug Delivery Compared to Systemic Delivery with Oral Medication

 

Intrathecal drug delivery enables patients to experience pain relief using a fraction of an oral medication dose,1-3 which can help to minimize the uncomfortable and sometimes intolerable side effects (e.g., drowsiness, dizziness, nausea, vomiting and constipation) that often accompany pain medication taken orally.2-5

Medtronic Targeted Drug Delivery also can provide pain relief in patients who cannot achieve adequate analgesia even with high doses of oral opioid medications.

This therapy is not for everyone. In addition to risks related to a surgical procedure, and drug related adverse events, pump or catheter problems can cause serious or fatal drug overdose or underdose, and may require corrective surgery. For additional safety information, please refer to Indications, Safety, and Warnings.

AN ALTERNATE ROUTE OF DELIVERY

While oral pain medications, such as opioids, are a mainstay in the legitimate treatment of chronic pain, they also are widely misused and abused. Inappropriate use of opioid pain medications is reaching epidemic proportions in the United States where nearly three out of four deaths from prescription drug overdoses are caused by oral pain medications.6

Physicians have little control over how patients use oral pain medication prescriptions. Once patients leave the office, they may take the medications at their own discretion. In addition, those prescription medications can be easily sold, stolen, and shared.

As an alternate route of delivery for providing pain medication to appropriate patients, Medtronic Targeted Drug Delivery can lead to a lower risk of drug misuse and diversion in contrast to pills, which can be easily diverted or otherwise taken inappropriately. Targeted drug delivery also enables physicians to hinder the diversion of oral pain medications by tapering patients off of oral opioids with the aim of exclusively delivering pain medication intrathecally.1-5, 7

Targeted drug delivery with the optional myPTM™ programmer allows patient-activated, bolus dosing of morphine within physician parameters —  to control — unpredictable pain, and can result in decreased intake of supplemental oral opioids.8


BENEFITS OF TARGETED DRUG DELIVERY

Benefits of treating chronic intractable pain with targeted drug delivery include:

  • Effective pain relief2,5,7-12
  • Reduced or eliminated use of oral pain medicines1-2,7-9,13
  • Return-to-work data9
  • Reduced side effects compared to oral medication2-5
  • Patient satisfaction8-9,12-15
  • Cost benefits16-17

MANAGEMENT OF INTRACTABLE CANCER PAIN

Cancer patients may benefit from targeted drug delivery, an alternate route of delivering pain medication. For example, based on data from a randomized clinical trial, the proportion of subjects who achieved reductions in pain and opioid-related toxicity was greater in patients who received a SynchroMed drug infusion system compared to those who received comprehensive medical management only.5

Research shows:

  • A majority of patients experience pain during their course of cancer treatment, and cancer pain impairs quality of life and function
  • The cost of inadequate pain control and the related side effects of pain medications is high, both in terms of impaired function and quality of life
  • Pain interferes with activities of daily living

RISKS OF TARGETED DRUG DELIVERY

Surgical complications are possible and include infection, headache, spinal fluid leak, meningitis, and paralysis. Possible complications include the catheter or pump moving within the body or eroding through the skin which may lead to additional surgery. The catheter could leak, tear, kink, or become disconnected. The pump could stop because it has reached end of service or because of failure of another of the part of the infusion system. Any of these situations may cause symptoms to return and may require additional surgery. Device malfunctions may result in clinically significant overdose or underdose. Acute massive overdose may result in coma or fatality. An inflammatory mass can form at the catheter tip and result in serious neurological impairment, including paralysis. The therapy may not meet the patient's expectations or may lose effect. Electromagnetic interference (EMI) and magnetic resonance imaging (MRI) may cause patient injury, system damage, operational changes to the pump, and changes in flow rate. See SynchroMed product labeling for more information.


1

Grider JS, Harned ME, Etscheidt MA. Patient selection and outcomes using a low-dose intrathecal opioid trialing method for chronic nonmalignant pain, Pain Physician 2011; 14:343-351.

2

Hamza M, Doleys D, Wells M, et al. Prospective study of 3-year follow-up of lowdose intrathecal opioids in the management of chronic nonmalignant pain. Pain Med. 2012;13:1304-1313.

3

Ruan X. Drug-related side effects of long-term intrathecal morphine therapy. Pain Physician. 2007;10:357-366.

4

Noble M, Treadwell JR, Tregear SJ, et al. Long-term opioid management for chronic noncancer pain. Cochrane Database of Systematic Reviews. 2010, Issue 1.

5

Smith TJ, Staats PS, Deer T, et al. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002;20:4040-4049.

6

Deer, T. R. et al (2017), The Polyanalgesic Consensus Conference (PACC): Recommendations on Intrathecal Drug Infusion Systems Best Practices and Guidelines. Neuromodulation: Technology at the Neural Interface, 20: 96–132. doi:10.1111/ner.12538.

7

Atli A, Theodore BR, Turk DC, Loeser JD. Intrathecal opioid therapy for chronic nonmalignant pain: a retrospective cohort study with 3-year follow-up. Pain Med. 2010;11:1010-1016.

8

Ilias W, le Polain B, Buchser E, Demartini L for the oPTiMa study group. Patient controlled analgesia in chronic pain patients: experience with a new device designed to be used with implanted programable pumps. Pain Pract. 2008;8(3):164-170.

9

Deer T, Chapple I, Classen A, et al. Intrathecal drug delivery for treatment of chronic low back pain: report from the National Outcomes Registry for Low Back Pain. Pain Med. 2004;5:6–13.

10

Raphael JH, Duarte RV, Southall JL, Nightingale P, Kitas GD. Randomised, double-blind controlled trial by dose reduction of implanted intrathecal morphine delivery in chronic non-cancer pain. BMJ Open. 2013;3(7):e003061.

11

Ellis DJ, Dissanayake S, McGuire D, et al. Continuous intrathecal infusion of ziconotide for treatment of chronic malignant and nonmalignant pain over 12 months: a prospective, open-label study. Neuromodulation. 2008;11:40-49.

12

Rauck RL, Wallace MS, Leong MS, et al. A randomized, double-blind, placebo-controlled study of intrathecal ziconotide in adults with severe chronic pain. J Pain Symptom Manage. 2006;31:393–406.

13

Roberts LJ, Finch PM, Goucke CR, Price LM. Outcome of intrathecal opioids in chronic non-cancer pain. Eur J Pain. 2001 5:353-361.

14

Duarte RV, Raphael JH, Sparkes E, Southall JL, LeMarchand K, Ashford RL. Long-term intrathecal drug administration for chronic nonmalignant pain. J Neurosurg Anesthesiol. 2012;24:63-70.

15

Winkelmüller M, Winkelmüller W. Long-term effects of continuous intrathecal opioid treatment in chronic pain of nonmalignant etiology. J Neurosurg. 1996;85:458-67.

16

Brogan SE, Winter NB, Abiodum A, Safarpour R. A cost utilization analysis of intrathecal therapy for refractory cancer pain: identifying factors associated with cost benefit. Pain Med. 2013;14:476-486.

17

Guillemette S, Witzke S, Leier J, Hinnenthal J, Prager JP. Medical cost impact of intrathecal drug delivery for noncancer pain. Pain Med. 2013;14:504-515.