Opioid Drugs Approved in Last Two Decades Lack Sufficient Safety Assessments

Researchers from George Washington University and the Johns Hopkins Bloomberg School have discovered that the data used to approve opioid pain medications by the FDA from 1997 to 2018 depended on intermediate or short-term studies that largely didn’t sufficiently examine safety outcomes. The findings, which were obtained from a cross-sectional analysis, were reported in the “Annals of Internal Medicine.”

The safety assessment and study details for every drug were examined. The investigators also amassed all 48 new drug applications for opioid goods that had been approved by the U.S. FDA for the treatment of chronic or acute pain.

Among the approved opioids, 47 had conducted pivotal trials before approval while 30 of the drugs sought approval via the pathway that allows drug applications to use published literature or data that had been previously submitted. Among the 48 drug applications, 10 were made available publicly.

The average number of pivotal trials that each approved drug had conducted was one. It was discovered that not all drug applications had fundamental data from placebo-controlled trials, with only 29 having conducted the trials.

Thirty-nine drugs were approved for use among patients with chronic pain, with six of these being approved for cancer-related uses. An additional nine others were approved for acute pain. The average duration that the chronic pain opioid products lasted was 84 days. No drug that had been approved was supported by both non-EERW and EERW trials, with 81% of the drugs having underlying studies with and EERW.

Of the drug applications for chronic pain, only 12.8% evaluated overdose symptoms; 17.9% evaluated deviating drug use, with 20.5% and 38.5% evaluating for diversion of the study drug and drug tolerance respectively. No drug study incorporated all these measurements to evaluate systematic safety.

However, preclinical studies weren’t incorporated into the data set in the study. Because many of these studies had followed the 505 (b)(2) regulatory pathway, some submitted proof that may have included important efficacy or safety data that supported their approval.

The data from this study emphasized that the 48 new opioid products that had been approved over the last two decades by the FDA were approved based on data from studies that barely lasted three months. Most included an inadequate assessment of safety and a narrowly defined population.

The researchers summarized that the findings proposed various opportunities for the FDA to increase the efficacy and safety data used to support the approval of new opioid products by using its regulatory discretion.

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