Not many medtech companies have the reach and scale of Medtronic. Yet, the Dublin-based firm is in the same position as any other device firm when it comes to the awareness and acceptance of alternatives to oral opioids.
Medtronic is hoping to change this with the help of its newly-launched Embrace Targeted Drug Delivery (TDD)clinical study. The 100-patient trial is a post-market study set to evaluate the use of the SynhroMed II intrathecal drug delivery system for patients with chronic intractable non-malignant primary back pain with or without leg pain. The first patient was enrolled in Embrace TDD last week.
“The medical device industry has not always been fully recognized as an alternative for patients suffering with chronic pain,” Charlie Covert, VP and general manager, Targeted Drug Delivery, Medtronic Pain Therapies, told MD+DI. “[The Embrace trial] we believe is an opportune moment for us to put medical devices at the forefront.”
Medtronic’s said the device provides effective pain relief at a fraction of the oral dose with fewer side effects and may help reduce or eliminate the use of oral opioids.The Embrace TDD study will follow patients who wean completely from all oral opioids and have a successful intrathecal drug trial.
“The trial itself is an evaluation of an approved therapy targeted drug delivery in most markets around the world,” Covert said. “It will demonstrate two things. One is that we can get these patients down and off of their systemic oral opioids. [The second] is that we can deliver a benefit clinically.”
The study will assess pain control and opioid-related side effects at six months following a route of delivery change to intrathecal preservative-free morphine sulfate. 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.
“If we can get patients converted from their systemic orals and onto a pump and show that their pain is better and that we’ve also reduced the toxicity and side effects that come with systemic oral opioids - then this will be a big win for medical device technology and in particular targeted drug delivery,” Covert said.
The opioid epidemic is a hot-button topic in the U.S. A panel at MD&M West will address medtech’s role in combating the misuse of opioids in a session titled The Opioid Crisis—Can Medtech Succeed Where Pharma Failed?” It will be held on Thursday, February 7, at 3p.m.
The industry as a whole was given a call to arms by FDA in June of last year, when the agency launched an innovation challenge to spur the development of devices, digital health technologies, and diagnostic tests that could provide a novel solution in response to the opioid epidemic.
Last year, Boston, MA-based Pear Therapeutics was able to get an FDA nod for the reSET-O, an app used to help those with opioid use disorder stay in recovery programs.
In addition, Bentley University and Gravity Diagnostics entered into a partnership that would allow researchers to begin exploring the genetic links between patients and opioid addiction. The research project aims to help better inform doctors on how likely a patient is to become addicted to opioids before ever prescribing to opioid drugs.