Key Evidence Supporting Prescription Opioids Approved by the U.S. Food and Drug Administration, 1997 to 2018

Analysis of new drug applications reviewed by FDA found only 21 products from 39 approved for chronic pain were supported by at least 1 pivotal trial, and 17 were approved on the basis of designs that excluded those with early adverse effects, or few immediate benefits.

Source:

Annals of Internal Medicine