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First Patient Enrolled in Intrathecal Drug Delivery System Study

Trial will examine the targeted system as an opioid alternative for chronic back pain

A PPM Brief

Medtronic (Dublin, Ireland) has announced1 that the first patient has enrolled in its Embrace Targeted Drug Delivery (TDD) clinical study which will evaluate the use of their product, the SynchroMed II intrathecal drug delivery system (the “Medtronic pain pump”). The tool has the potential to be an alternative to opioids for patients with chronic non-cancer back pain, with or without leg pain. The study will follow patients who wean completely off opioids and have a successful intrathecal drug trial, designed to further understand the impact of an opioid-free period prior to TDD treatment on patient outcomes.

The prospective, multi-center, post-market study with approximately 100 patients I will assess pain control and opioid-related side effects six months after a route of delivery change to intrathecal preservative-free morphine sulfate. Patients taking a daily systemic opioid dose of less than or equal to 120 morphine milligram equivalents (MME) and who are candidates for TDD will be considered eligible and will be followed for 12 months.

Trial will examine SynchroMed II as an opioid alternative for chronic back pain. (Source: 123RF)

"We hope the Embrace TDD study will provide valuable insights about how to best optimize use of the Medtronic pain pump and enable clinicians to help more patients with chronic pain, which has a significant personal and societal impact," said Charlie Covert, vice president and general manager of Targeted Drug Delivery, Medtronic Pain Therapies, in a press release.

The system’s pain pump and catheter are implanted under the skin and deliver medication into the intrathecal space, enabling clinicians to prescribe reduced doses and tailor drug delivery to patient needs. 

Last updated on: February 1, 2019
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