The FDA has approved opioids based on limited data, sometimes “defective” trial designs

September 28, 2020 Time required: 2 minutes Source / Disclosure Disclosure: Alexander reports that he was the former chair of the FDA's Peripheral and Central Nervous System Advisory Board. He is a paid advisor to IQVIA. Being a co-founding principal and equity holder of Monument Analytics. And as a member of OptumRx's National Pharmacy and Treatment Committee. Add topic to email alert Receive an email when a new article is posted Please enter your email address to receive an email when a new article is posted .. "data-action subscribe> subscribe The request could not be processed. Please try again later.If you continue to have this issue, please contact us customerservice@slackinc.com.. Return to Healio Researchers often say that the FDA approves new opioid drug applications based on inappropriate length trials in patients who can tolerate the drug only... "Despite the extent of the ongoing opioid epidemic in the United States, little is known about the FDA's approval of new opioid products over the last two decades." G. Caleb Alexander, MD, MS, Johns Hopkins Bloomberg, a professor at the Center for Drug Safety and Effectiveness at the Graduate School of Public Health, told Healio Primary Care. "We investigated one of the key aspects of opioid regulation, the high standards set by the FDA for new products to market."Alexander and colleagues investigated 48 new drug applications (NDAs) approved by the FDA between 1997 and 2018. Chronic pain remedy According to researchers, most of the 48 NDAs were evaluated for new dosage forms (52.1%) or new formulations (18.8%), and only one was evaluated for new molecular entities. Of the 39 NDAs approved for the treatment of chronic pain, 21 were supported by at least one important trial. The median of these trials was 299 (IQR 174–525), with a median of 84 days (interquartile range). 25-84 days). "Many people take these medicines Much longer period"Alexander said. The researchers also found that 17 of these products were approved based on a study design that excluded patients who were intolerant of the drug, had early side effects, or had little reported immediate benefit. discovered. Enhanced Registration Random Drawer (EERW) Design, Alexander called it "fundamentally flawed." Only 8 NDAs for chronic pain (20.5%) included pooled safety reviews that reported a systematic assessment of detours, and 7 (17.9%) reported systematic measurements of non-medical use of opioids. However, 15 (38.5%) evaluated the development of tolerance. Acute analgesics Alexander and colleagues reported that eight of the nine NDAs for acute pain were supported in at least one important trial. These trials enrolled a median of 329 patients (IQR 199–456), followed by a median of 1 day (IQR 1-2 days). The researchers said none of the important trials of acute analgesics followed the design of EERW. Alexander said that while reports of "voluntary or" unrestricted "adverse events were common, systematic collection of other important information, such as opioid diversion and non-medical use, was rare. "The FDA could have asked pharmaceutical companies to generate much more useful and clinically relevant information about the safety and efficacy of prescription opioids," he said. A spokesperson for the FDA points out that the FDA is using research "to better understand specific issues and support our mission to protect public health," and commented on the findings. I refused to do that. Add topic to email alert Receive an email when a new article is posted Please enter your email address to receive an email when a new article is posted .. "data-action subscribe> subscribe The request could not be processed. Please try again later.If you continue to have this issue, please contact us customerservice@slackinc.com.. Return to Healio Opioid Resource Center Pictures Credit

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The FDA has approved opioids based on limited data, sometimes “defective” trial designs

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The FDA has approved opioids based on limited data, sometimes “defective” trial designs

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