OPERA study evaluates patient perceptions of pain treatment with use of transdermal formulations

Clarity, a global international scientific research company, based in Austin, Texas, announces the latest results of its IRB-approved OPERA study. OPERA (Optimizing Patient Experience and Response to Topical Analgesics) evaluates patient perceptions of pain treatment with the use of FDA-approved topical/transdermal formulations alone or in combination with neuropathic supplements via a patient-reported survey.

Latest analysis indicates participants continue to see a reduction of 45% of opioid usage and a significant reduction of non-opioid drugs to treat chronic pain. There were also minimal reported side effects.

Launched in October 2014, this is the fourth interim analysis of the OPERA study. It now includes 100 clinician investigators and over 1000 patients, both men and women, ranging in age from 18 to 64. The purpose of the fourth interim analysis is to:

Validate findings from previous interim analyses (n= 417 and n= 631), but with topical use extended to 5 months
Evaluate the efficacy of the topical analgesic in reducing pain in patients experiencing either neuropathic or musculoskeletal pain, using the Brief Pain Inventory (BPI) Short Form
Assess changes in use of opioids and other oral pain medications
Assess patient satisfaction with the topical analgesic
Identify any adverse effects
"We were inspired to undertake this study because clinically we have recognized a pain-relieving and opioid-sparing effect to topically applied analgesics and were pleased that this latest analysis is consistent with earlier interim results," states Dr. Jeffrey Gudin, Lead Investigator of the Study. "We hypothesized that these logical alternative treatments to oral medications may reduce adverse events, reduce pain severity scores and improve quality of life for patients with chronic pain. In addition, these therapies are certainly not associated with the stigma of traditional oral opioids."

"According to the Centers for Disease Control, in 2014 almost 2 million Americans abused or were dependent on prescription opioids and every day over 1,000 people are treated in emergency departments for misusing those same drugs," notes Dr. Dennis Harris, Chief Medical Officer at Clarity Science. "That's why these results are gaining national and international attention from physicians who are seeking viable alternative approaches for their pain patients."

Among other findings to be presented at the AAPM, specific patient observations from the latest analysis include:

91 percent of patients found the topical analgesics convenient to use
96 percent reported them easy to apply
85 percent preferred them over an oral medication
99 percent were either very or somewhat satisfied with the topical analgesic
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.