Exclusive article by Isaac Christiansen at EMRIndustry.com
Researchers at Ohio State University have developed a cutting-edge treatment for back pain sufferers that has the potential to reduce dependence on opioids. Roughly the size of a large sesame seed, an implant that releases low doses of a non-habit forming painkiller may be the key to halting the rising tide of opioid addiction.
The Urgent Need for Opioid Alternatives
Opioids are effective at combating intense pain, and are commonly prescribed for chronic pain and after surgery. As more and more physicians began prescribing opioids for their patients, however, public health officials became aware of a troubling side effect: a great potential for addiction. Studies have shown that up to one in four patients who are prescribed prescription opioids by a primary care physician for chronic, non-cancer pain develops issues with drug dependence. The highly addictive nature of opioid drugs alone with increased prescribing and little to no regulatory oversight has lead to an epidemic of substance abuse and opioid addiction in the United States.
A New Frontier in Pain Management
Avoiding opioid use completely is the current goal for many physicians, in order to avoid their associated risks. Even postoperative opioid use is being reconsidered. This has opened up a new field in pharmaceutical research and development. Focusing on the need for opioid alternatives, scientists are broadening the scope of potential pain treatments. A new pain-killing implant was designed by researchers at the Wexner Medical Center at the Neurological Institute of Ohio State University with the current opioid crisis in mind.
Physicians focused on disrupting the pain feedback cycle developed a tiny, rod shaped implant to ease the chronic discomfort of lower back pain. Functioning similarly to a spinal epidural, the rod is implanted in the back at a precise location. This implant releases a low dose of medication that is absorbed into the bloodstream. The specific painkiller used in the device is a closely guarded secret that the researchers will not reveal at this time. However, it is known that the medication is not a steroid or opioid, and developers have shared that it is a cardiovascular drug with an established history of successful use.
Promising Initial Trial and a Possible Fast Track to Market
In a modest clinical trial of 55 back patients suffering from sciatica, a painful condition marked by leg and lower back pain, the implant alleviated chronic pain and had few side effects. The nature of the implant meant that compliance with the treatment was 100%. The success of this initial study has led researchers to design a larger trial to establish safety and efficacy. Patients recruited from pain centers in Ohio will be subjects in this larger clinical study. If this study shows the same promising results as the initial outcomes, researchers will apply for approval from the Food and Drug Administration. Ideally, the implant will become available to physicians and patients in four to five years. This is possible because although FDA approval can take seven years or more, there are no currently available approved treatments for sciatica, making the FDA review a priority.
While the initial trials and FDA application will focus on sciatic pain, this treatment also shows promise for those suffering chronic pain resulting from other conditions. Migraines, nerve pain, fibromyalgia, and joint pain from osteoarthritis diseases like glenohumeral arthritis, all result in chronic pain for sufferers who require medical intervention for relief. Alternatives to opioids like the device created by the Wexner Medical Center has great potential to alleviate the pain suffered by these patients without risk of drug dependence. The implant is effective because it actually stops the pain rather than merely masking in the way that opioids do. It interrupts the pain signals before they reach the brain thereby reducing the inflammation that normally results. This leads to nerves that are less sensitive to stimuli, breaking the pain feedback loop.
Powerhouse Research and Development Team
To raise funds and advance the development of this groundbreaking medical device, startup Sollis Therapeutics was launched. Sollis is led by chief executive officer Dr. Greg Fiore, a pharmaceutical consultant and non-practicing physician, and chief operations officer Bryan Jones, a geneticist with a background in cancer pain. Dr. Ali Rezai, director of the Neurological Institute at OSU that invented the device, serves in an advisory capacity. With such an experienced team at the helm, this new pain management treatment is surely just the beginning of a future filled with choices for patients suffering with chronic pain.
