Assessment of NDAs for opioids for chronic pain – how searching are the criteria used for assessment?

An analysis recently published in The Annals of Internal Medicine has found that most of the 48 New Drug Applications (NDAs) for opioid analgesics approved by the FDA between 1997 and 2018 assessed new dosage forms (n = 25 [52.1%]) or new formulations (n = 9 [18.8%]); only 1 (2.1%) was for a new molecular entity. There were 39 NDAs approved for treating chronic pain, but only 21 products were supported by at least one pivotal trial – of these, a substantial number of trials (n = 28) had a median duration of 84 days (interquartile range [IQR], 25 to 84 days) and enrolled a median of 299 patients (IQR, 174 to 525 patients). Seventeen (81%) of these products were approved on the basis of designs that excluded patients who could not tolerate the drugs, had early adverse effects, or reported few immediate benefits. In the context of the ongoing opioid crisis, it it of critical significance that for NDAs addressing chronic pain, only 8 (20.5%) included pooled safety reviews that reported systematic assessment of diversion, 7 (17.9%) reported systematic measurement of non-medical use, and 15 (38.5%) assessed development of tolerance. It would appear that the approval processes involved in assessing NDAs may indeed be contributing to some of the issues that underpin the opioid crisis. Read more here.