Researchers discovered that only 21 of the 39 opioids approved by the FDA from 1997 to 2018 were supported by at least one pivotal trial. The median length of the trials conducted for opioids during this time was 84 days.
The study also found that of the 21 products backed by a pivotal trial, 17 (81 percent) excluded participants who could not tolerate the drugs, and most trials failed to examine risks associated with tolerance, addiction and drug diversion. Its conclusion states that “systematic collation of certain important safety outcomes was rare.”
More articles on opioids:
Senators urge bankruptcy judge to block Purdue Pharma CEO’s $3.5 million bonus
New York hits J&J with lawsuit over opioid marketing
Taxing drugmakers, distributors for opioid treatment programs upheld by US appeals court
