TUESDAY, Sept. 29, 2020 (HealthDay News) — New drug applications (NDAs) for prescription opioids for pain have been based on pivotal trials of short or intermediate duration, often in narrowly defined pain populations, according to a study published online Sept. 29 in the Annals of Internal Medicine.
James Heyward, M.P.H., from the Johns Hopkins Bloomberg School of Public Health in Baltimore, and colleagues characterized the quality of safety and efficacy data in NDAs for opioid analgesics approved by the U.S. Food and Drug Administration between 1997 and 2018.
The researchers found that 25 and nine of the 48 NDAs evaluated were for new dosage forms and new formulations, respectively; one was for a new molecular entity. Thirty-nine NDAs were approved for treating chronic pain; of these, only 21 products (28 trials) were supported by at least one pivotal trial. These trials had a median duration of 84 days, with enrollment of a median of 299 patients. Most products (17; 81 percent) were approved based on designs excluding patients who could not tolerate the drugs, had early adverse effects, or reported few immediate benefits. Of the nine products for acute pain, eight were supported by at least one pivotal trial; the 19 trials had a median duration of one day, with enrollment of a median of 329 patients.
“These findings 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,” the authors write.
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