Clarity Updates OPERA Clinical Study Interim Results Showing 45% Reduction of Opioid Usage Following Treatment of Transdermal Pain Medication

"Clarity is clearly providing a positive disruption in the delivery of this alternative treatment to opioids," said Brad Wilson, President and CEO of Blue Cross and Blue Shield of North Carolina, and a Board Member of Safe Harbor Compliance and Clinical Services. "The new study data showing a 45% reduction in opioid usage can have a clear impact on the quality of life to an individual and a positive economic impact in healthcare." 

"The overall solution to the opioid epidemic is complex," said Sara Finley, Principal of Threshold Corporate Consulting, LLC, and a Board Member of Safe Harbor Compliance and Clinical Services. The OPERA study data brings a new conversation around alternative treatment for chronic pain management that hopefully will lead to further collaboration with Clarity by health plan payors, pharmacists and PBMs to address this problem."

According to the American Society of Addiction Medicine, drug overdose is the leading cause of accidental death in the US, with 47,055 lethal drug overdoses in 2014. Opioid addiction is driving this epidemic, with 18,893 overdose deaths related to prescription pain relievers, and 10,574 overdose deaths related to heroin in 2014.

Lead Study Investigator, Jeffrey Gudin, MD, states, 

"Topical analgesics have the advantage of local application with limited systemic levels of drugs. Because of the lower systemic exposure observed with topical or transdermal therapies, there may be a benefit from reduced side effects, a lower risk of drug-drug interactions and improved tolerability. Therefore, the evaluation of opioid-sparing treatments including topical/transdermal compounded formulations is critical to identification of safer and more effective approaches to the treatment of pain."

Obama Administration Letter

In May 2016, Clarity Science received recognition from the Deputy Director for Policy, Research & Budget on behalf of the President of the United States.

The letter identifies that our transdermal research "may be an effective tool in reducing the overprescribing of opioid medications."

We were thanked for our "ongoing efforts to help tackle some of our Nation's enduring challenges, and for (our) offer to be of service in support of alternative therapies for pain management to reduce the risk of addiction."

Dr. Dennis Harris, Chief Medical Officer of Clarity shares, "Our most recent interim data shows a 45% reduction of opioid usage among study participants. The study is creating a great deal of interest among physicians who are looking at these results to determine if this is a viable alternative approach for their pain patients." 

OPERA Assessment Tools

The OPERA (Optimizing Patient Experience and Response to Topical Analgesics) study evaluates patient pain scores using the University of Texas MD Anderson Cancer Center's Brief Pain Inventory (BPI). The BPI is a validated tool for assessing the severity of pain and the impact of pain on daily functions of patients with cancer pain and pain due to other chronic disease. MD Anderson Cancer Center granted Clarity express authorization to use the BPI for the OPERA study. 

The Study Results to Date

OPERA evaluated participants using a topical/transdermal analgesic formulation for pain and are reporting positive results: (n=631; p<.001)

• Reduced use of opioid analgesics, anti-inflammatory medications, and over-the-counter medications
• Reduced pain severity for patients with neuropathic and musculoskeletal pain
• Reduced pain interference with general activity, mood, sleep, and life enjoyment
• Reduced number of primary pain complaints for arthritis, neuropathy, or radiculopathy
• 95% of patients were satisfied with the topical analgesic, and the topical analgesics were safe and well-tolerated

Principal Investigators of the study are Jeffrey Gudin, MD, Director, Pain and Palliative Care, Englewood Hospital and Medical Center, New York, NY; and Michael J. Brennan, MD, CMO of the Pain Center of Fairfield, CT. 

OPERA Results Presentations

Latest results of the study will be presented at the National Pain Week Conference September 6 – 10 in Las Vegas. It is the nation's largest pain conference for front-line clinicians with an interest in pain management.

Clarity has also been invited to present data from the IRB-Approved OPERA Study at the International Association for the Study of Pain (IASP)'s, 16th World Congress on Pain, September 26 – 30, in Yokohama, Japan.

For more information on the OPERA and other studies, please visit https://clarityscience.com/studies-outcomes/#current-studies.

To learn more about becoming about investigator, please visit: https://clarityscience.com/become-an-investigator/

About Clarity Science

Clarity Science is a global scientific research company whose goal is to advance science and improve patient health. Led by a team of experienced healthcare professionals and guided by leading board-certified healthcare attorneys, Clarity specializes in conducting research in the areas of allergy, pain, scar/wound healing, genomics, women's health, cardio metabolic disorders, and oncology.
For more information, please call Peter Hurwitz, President, Clarity Science at 1-800-641-4857 or visit www.clarityscience.com

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SOURCE Clarity Science

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