An NIH imperative is to find effective and non-addictive strategies to manage chronic pain. Neuromodulation devices that provide targeted electrical stimulation to alleviate or eliminate pain are but one potential solution. Find out more details in this Frost & Sullivan analysis.
Pharmaceutical treatments for episodic or long-term pain come with risks ranging from side effects and toxicity to the development of tolerance or addiction. Indeed, the National Institute on Drug Abuse, a nonprofit research organization under the National Institutes of Health (NIH), traces today’s opioid crisis in the United States to the overprescription of pain relievers that began in the late 1990s and resulted in widespread misuse and addiction. A 2016 U.S. Centers for Disease Control and Prevention (CDC) report noted that as late as 2012, health care providers wrote 259 million prescriptions for opioid pain medication—enough for every U.S. adult to have a bottle of pills. Addicts can look for their next fix beyond prescription drugs by turning to heroin or illicit fentanyl, which is a potent synthetic opioid. The CDC found a spike in the number of annual overdose deaths from synthetic opioids other than methadone just in the past few years: from less than 5,000 in 2013 to more than 20,000 in 2016, surpassing the number of cocaine and methamphetamine overdose deaths combined—and even the number of heroin deaths—for the year.
The CDC’s ongoing National Health Interview Survey found that in 2016, 28.4% of U.S. adults reported suffering lower back pain that lasted a day or more, while 15.3% suffered migraines or other types of severe headaches. Frost & Sullivan, in a 2016 global study of neuromodulation technologies, determined that headache therapies are among the most commercially attractive targets, with research intensity that is only surpassed by the pursuit of treatments for psychiatric disorders.
An NIH imperative is to find effective and non-addictive strategies to manage chronic pain. Neuromodulation devices that provide targeted electrical stimulation to alleviate or eliminate pain are but one potential solution. Two U.S. companies have made significant strides in headache therapy—one with a minimally invasive system and the other with a noninvasive device whose scope has already expanded to target other conditions as well. For lower back pain treatment, implantable devices are more common, though one company is exploring an alternative to this invasive procedure. Details about each follow.
Autonomic Technologies (Mountain View, Calif.)
The Cleveland Clinic Innovations spin-off company developed a minimally invasive, two-component nerve stimulation system for the treatment of headaches. The Pulsante system received European CE marking in 2012 for the treatment of cluster headache (a sudden, intensely painful, debilitating series of attacks concentrated on one side of the head that strike daily or several times a day and can either be episodic—over a period of several weeks—or chronic); in March 2017 the approval was expanded for the treatment of patients who are considered to be highly disabled by migraines. In the United States, Pulsante has received an investigation device exemption for the study of its use to treat chronic cluster headache.
The system is an alternative to conventional acute treatments that include injectable medication, the inhalation of pure oxygen, and oral or intranasal medication that may take too long to act because of the pain’s rapid onset. In an outpatient procedure, a wireless microstimulator and lead is positioned at the sphenopalatine ganglion nerve bundle through an upper-gum incision on the side of the patient’s pain. A physician can customize settings but the patient is in control of the treatment, which involves simply placing a remote controller about the size of a smartphone against the cheek at the onset of an attack.
electroCore (Basking Ridge, N.J.)
The 13-year-old company developed a noninvasive vagus nerve stimulation therapy in 2010 that received its first U.S. Food and Drug Administration (FDA) clearances within the past year. The prescription-only gammaCore evokes a Norelco electric shaver. A patient simply applies a conductive gel to two circular stimulation surfaces on the handheld device and positions it against the neck to deliver two-minute doses in groups of three—up to 24 doses per day. The device received FDA clearance in April 2017 for the treatment of adults with episodic cluster headache, and 501(k) clearance in January for its introduction as a migraine treatment; availability is expected in this quarter of 2018. Safety and efficacy has not been established for the treatment of chronic cluster headache.
In Europe, the device is also approved to treat or prevent symptoms of reactive airway disease (e.g., asthma and chronic obstructive pulmonary disease) and as an adjuvant therapy for adults to alleviate symptoms of a variety of anxiety, depression and gastric disorders, and in the prevention of epileptic seizures.
SPR Therapeutics (Cleveland, Ohio)
Spinal cord stimulation is an accepted lower back pain treatment, but SPR Therapeutics has developed an alternative to the invasive procedures required for the use of products such as ReActiv8 therapy by Mainstay Medical (Dublin, Ireland), which targets the dorsal ramus nerve.
The company recognizes the dangers of opioid addiction and has specifically cited the problem, and the fact that its home state ranks among the top in the country for overdose deaths, in its publications. A U.S. study of SPR Therapeutics’ SPRINT peripheral nerve stimulation system for the treatment of chronic low back pain is recruiting study subjects to have as many as four 0.2 mm leads percutaneously placed in their lower back muscles for electrical stimulation by an attached, lightweight wearable. The study has an estimated completion date of July 2019. The system, which the FDA has cleared for use for up to 60 days, also is being studied for its effects on chronic post-amputation pain and post-operative total knee arthroplasty pain.
The Road Ahead
Frost & Sullivan found that more than half of all investments in the global neuromodulation industry (including but not limited to pain treatment) in 2016 were for the development of invasive technologies. Funding for research on minimally or noninvasive technologies was evenly split, at 22% each. As interest in the latter technologies increases, it could open the door for consumer electronics companies and other nontraditional participants to step in to fill market gaps either on their own on by partnering with industry leaders. Samsung, for example, has partnered with medical device giant Medtronic to develop Android-based tools that will help physicians and patients manage therapy using real-time data that is securely collected and transmitted via smartphones or wearables.
Specifically for pain management, consumers themselves may be part of a sea change as they demand alternatives to addictive pharmaceuticals. Companies that can be among the first to deliver would be held up as models by the government and service organizations.
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