Medtronic has started enrolling patients in the Embrace TDD clinical study evaluating SynchroMed II intrathecal drug delivery system to treat chronic intractable non-malignant primary back pain, with or without leg pain.
The Medtronic pain pump and catheter will be implanted under the skin to deliver medication into the intrathecal space. This approach is expected to facilitate lower doses than systemically delivered drugs.
The pain pump is meant to provide an alternative to oral opioids. It is claimed to offer effective pain relief at a fraction of the oral dose.
Medtronic added that the device causes fewer side effects and has the potential to help decrease or avoid the use of oral opioids.
The prospective, multi-centre, post-market Embrace TDD study will recruit 100 patients who wean completely from all oral opioids before beginning intrathecal therapy.
To be conducted at up to 15 US sites, the study will monitor pain control and opioid-related side effects at six months after a change in route of administration to intrathecal preservative-free morphine sulfate.
Medtronic Pain Therapies Targeted Drug Delivery vice-president and general manager Charlie Covert said: “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.
“We hope the Embrace TDD study will provide valuable insights about how to best optimise use of the Medtronic pain pump and enable clinicians to help more patients with chronic pain, which has a significant personal and societal impact.”
Previous research found that oral opioid adjustment and elimination could improve pain relief and enable a lower intrathecal medication dose, compared to oral and intrathecal treatment combinations.
The new Embrace TDD study is intended to gain further insights into the impact that an opioid-free period before targeted drug delivery treatment may have on patient outcomes.