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For the past two decades, data submitted to the U.S. Food and Drug Administration (FDA) for new opioid approvals has lacked critical safety and efficacy information. During this period, the FDA approved opioids based on pivotal studies of short and medium duration, often in narrowly defined pain populations, with the exception of patients who did not tolerate the drug. Cross-sectional analysis results are published in Annals of Internal Medicine.

The per capita use of opioids in the US remains at epidemic levels and far exceeds that of other countries. Overdose rates are at an all-time high, largely due to heroin use and fentanyl use. However, most users of these illicit drugs report that their first opioid was a prescription drug. Given the role that prescription opioids have played in fighting the epidemic, the FDA’s regulatory activities have been reviewed. Little is known about the evidence required by the FDA for new approvals of opioid analgesics.

Researchers at the Johns Hopkins Bloomberg School of Public Health examined 48 new drug submissions (NDAs) for opioid analgesics submitted to the FDA between 1997 and 2018 to characterize the quality of the safety and efficacy data included in the submissions. Researchers focused on drugs that are approved for chronic pain because of the increased safety concerns with these drugs. The data showed that the FDA has approved 48 NDAs for prescription opioids for pain since 1996. The NDAs were based on pivotal studies that lasted no longer than 12 weeks and were often conducted in narrowly defined pain populations. Few approvals contained or related to pooled safety assessments that included systematic assessments of opioid-associated risks such as tolerance, drug diversion, and non-medical use. People who did not respond to a product or otherwise tolerated it were often excluded from the studies. According to the researchers, their results suggest several opportunities for the FDA to use its regulatory discretion to increase the safety and efficacy data generated in support of new opioid approvals.

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More information:
Annals of Internal Medicine (2020). Provided by the American College of Physicians

Quote: For two decades, the FDA has approved new opioids based on studies with no critical safety and efficacy data (2020, September 29) posted on September 29, 2020 at decades-fda-opioids were obtained, consistently admitted -based-absent.html

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