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Precision Medicine Trial Shows Reduced Pain, Opioid Use

Stethoscope on DNA sheet

(National Heart, Lung, and Blood Institute)

1 June 2017. A large-scale clinical trial tracking pain treatments guided by genetic testing shows large majorities of participants report less pain, with fewer individuals using opioid drugs. The first results of the trial were reported yesterday by its sponsor, Proove Biosciences Inc. in Irvine, California.

Proove Biosciences is developing diagnostics for pain based on analyzing an individual’s molecular characteristics, rather than subjective assessments by the patient or physician. The analysis includes genetic testing, supplemented by data from the person’s medical history, functional abilities, ethnic background, and stress levels, to provide an individual profile with evidence-based assessments of the factors contributing to the pain that person experiences.

Among the genetic tests are assessments of variations in the catechol-O-methyltransferase or COMT gene, responsible for enzymes that produce, among other things, neurotransmitters in the brain such as dopamine and norepinephrine. These neurotransmitters send chemical signals including sensitivity to and perceptions of pain. Genetic analyses can also provide data predicting a person’s responsiveness to treatment options, including ability to metabolize different drugs. The result, says the company, is a more personalized diagnosis and treatment plan rather than a trial-and-error approach followed in some current treatment strategies.

The clinical trial plans to recruit 50,000 participants at a large number of pain clinics in the U.S., although the initial results report on nearly 27,000 participants from 170 sites. The study is observational, meaning it reports on experiences of participants rather than testing specific treatments against a placebo or each other. All participants received a Proove Biosciences diagnosis, and were monitored first for 60 days to report on pain levels, changes in functional abilities, and medications, and then for 2 years to report on adverse effects.

The company says the vast majority of participants report considerably less pain when following treatment plans recommended by the Proove profiles. Some 94 percent of respondents, says Proove, report an average reduction in pain of 43 percent within 60 days. Pain levels were measured on standard self-reported assessment scales, where participants averaged scores of 7.7, or severe pain, before treatment and 4.4, or moderate pain levels after treatment.

In addition, about 3 in 4 (77%) participants responded favorably to medication changes guided by Proove profiles. Among those changes were less use of opioid pain relievers, reported by 14 percent of participants. A comparison of pain levels reported by participants taking opioid medications versus non-opioid drugs shows no differences large enough to be statistically reliable.

The company did not report any data on adverse effects, but says it plans to publish full results of the trial. Study leader Maneesh Sharma, from the Interventional Pain Institute in Baltimore, says in a company statement, “Proove profiles provide assessments regarding pain sensitivity, opioid abuse risk, and treatment response. It’s important to evaluate how this information is used by a clinician and more importantly, whether it helps clinicians make better treatment decisions.”

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