By Ed Coghlan.
Medtronic plc announced it has enrolled the first patient in a clinical study that will evaluate the use of its SynchroMed drug delivery system as an alternative for oral opioids.
The study is aimed at patients with chronic intractable non-malignant primary back pain with or without leg pain.
The company believes its pain pump—SynchromMed II– can provide effective pain relief at a fraction of the oral dose with fewer side effects.
The study—which the company has dubbed The Embrace TDD study—will follow patients who wean completely from all oral opioids and use their therapy to address their pain.
The Medtronic pain pump and catheter are implanted under the skin and deliver medication into the intrathecal space, enabling clinicians to prescribe reduced doses compared to systemically delivered medications and tailor drug delivery to patient needs.
“There are several strategies to approach weaning prior to or following TDD treatment. The Embrace TDD study is important because it will evaluate the impact of weaning patients completely off oral opioids before treating them with intrathecal therapy using the Medtronic pain pump,” said John A. Hatheway, M.D., owner and provider, Northwest Pain Care, Spokane, Washington who enrolled the first patient. “My goal is to provide patients with effective pain relief and help them eliminate long-term oral opioid use. Understanding the effect of being opioid free prior to TDD treatment may be clinically relevant as clinicians seek to optimize the use of long-term alternatives to oral opioids.”
The Embrace TDD study is a prospective, multi-center, post-market study that will enroll approximately 100 patients. Patients taking a daily systemic opioid dose of ≤ 120 Morphine Milligram Equivalents (MME), who are candidates for TDD, are eligible. Patients will be followed for 12 months. More details can be found at ClinicalTrials.gov.
“As part of our commitment to helping address the opioid crisis, Medtronic is investing in clinical research and tools that can increase understanding of how to use proven alternative treatments, like TDD, for patients with uncontrolled chronic pain,” said Charlie Covert, vice president and general manager, Targeted Drug Delivery, Medtronic Pain Therapies. “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.”