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How Can Medtech Help with the Opioid Crisis?

Focus on strategies that treat patients before they go on opioids, says a medical doctor and medtech innovator speaking in an upcoming MD&M West 2019 panel discussion.

Dr. Peter Staats, co-founder and chief medical officer of electroCore

Pain control is one of the biggest challenges facing America today, believes Dr. Peter Staats, co-founder and chief medical officer of electroCore. Chronic pain is an ongoing, debilitating problem for many patients, but for some, overuse of opioid treatments has led to addiction. Such a condition has led to an increasing number of U.S. deaths—one study published in the JAMA Network Open1 found that the percentage of all U.S. deaths attributable to opioids increased 292% between 2001 and 2016. This same study reported that in 2016, 20% of deaths of adults aged 24 to 35 years involved opioids.

Efforts to prevent future addiction and death has tightened opioid access, leaving many patients with few options.

“Two problems remain—uncontrolled pain and addiction,” Staats told MD+DI. “It’s my passion to address this challenge.” At MD&M West 2019, Staats will be speaking in the upcoming Center Stage session, “The Opioid Crisis—Can Medtech Succeed Where Pharma Failed?” on Thursday, February 7, at 3:00 PM. Staats will be joined by John Hsu, CEO and founder, iPill Dispenser; Greg Houlgate, founder and chief business and product development officer, Oska Wellness; and Srini Nageshwar, CEO, DyAnsys.

Staats has worked for years on developing and implementing minimally invasive procedures for chronic pain. He founded and served as director of the Division of Pain Medicine at Johns Hopkins University. He also served as a past president of the North American Neuromodulation Society, American Society of Interventional Pain Physicians, New Jersey Society of Interventional Pain Physicians, and the Southern Pain Society. He is currently chairman of the board of Examination of the World Institute of Pain and continues to serve as Chief Medical Officer for National Spine and Pain Centers. This year Staats will be honored with the lifetime achievement award from the North American Neuromodulation Society, which will accompany his prior recognitions including lifetime achievement awards from the NY NJ Societies of Interventional Pain, the 2018 American Society of Interventional Pain Physicians (ASIPP) 20th Annual Meeting, and the West Virginia Society of Interventional Pain Physicians.

For potential solutions, Staats encourages people to review the U.S. Department of Human Health and Services (HHS) Pain Task Force’s Draft Report on “Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations.” The report suggests “a multidisciplinary approach to chronic pain that focuses on the patient’s medical condition, co-morbidities, and various aspects of care.” Among several suggested approaches are interventional procedures, one of which is neuromodulation. “This is an area of growth and innovation for chronic pain treatment, including neuropathic pain, and for both the central and peripheral nervous system,” according to the report. For instance, “there are now multiple level-1 studies and multiple level-2 studies demonstrating that non-invasive vagus nerve stimulation can be effective in ameliorating pain in various types of cluster headaches and migraines. These therapies provide an electric field to the brain, cranial nerves, or peripheral nerves without actually requiring a surgical procedure or implant.” The 90-day comment period ends April 1, 2019.

Staats is hopeful about neuromodulation given his experience as past president of the North American Neuromodulation Society as well as co-founder and chief medical officer of electroCore. The company has developed gammaCore Sapphire, a non-invasive vagus nerve stimulator (nVNS) therapy, which is currently indicated for adjunctive use for the preventive treatment of cluster headache and for the relief of pain associated with migraine and episodic cluster headache.

“Neuromodulation has been around for a number of years, initially as a spinal cord stimulator implant,” he said. “Because initial procedures involved use of implants, which involve an invasive procedure and can be expensive, neuromodulation for many years was an end-of-the-road therapy.”

electroCore is now trying to take gammaCore Sapphire “to the beginning of the road.” Cluster headaches and migraine headaches “are very painful disorders,” he said. “Our studies have demonstrated decreased pain. Our goal is to treat patients before they need an opioid. If the pain is no longer there, patients may not need opioids.”

electroCore’s business model is different from most medical device companies’ models. “The first month of therapy has a set price,” Staats said, “and just like a pharmaceutical, you don’t have to refill it if it doesn’t work.” The company is still working on reimbursement through insurance plans, but it was just added to the Federal Supply Schedule as a negotiated therapy through the Department of Veteran’s Affairs, Department of Defense, Bureau of Prisons, Indian Health Servicesand Public Health Services, he added.

For innovators working on their own ideas for treating chronic pain, Staats urges them to be compassionate. “Understand addiction, and focus on a strategy that treats patients before they go on an opioid,” he said. In addition, there is “still a need to treat opioid addiction. There are ideas out there—one is a device that would reduce withdrawal symptoms. Many people are naive to think you can treat addiction with just a pill; you need a comprehensive strategy.”

Learn how you could help by attending “The Opioid Crisis—Can Medtech Succeed Where Pharma Failed?” on Thursday, February 7 at 3:00 PM at Center Stage.

Reference

1. "The Burden of Opioid-Related Mortality in the United States," Tara Gomes, PhD, et al, JAMA Netw Open. 2018.

Daphne Allen

Daphne Allen is editor-in-chief of MD+DI. She previously served as executive editor of Pharmaceutical & Medical Packaging News, which serves as the pharmaceutical and medical device channel of Packaging Digest. Daphne has covered medical device manufacturing, packaging, labeling, and regulatory issues as well as pharmaceutical packaging and labeling for more than 20 years. She is also a member of the Institute of Packaging Professionals's Medical Device Packaging Technical Committee. Follow her on Twitter at @daphneallen.

 

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