New Opioids: Industry Stakeholders Support US FDA's Desire For Active Comparator Data

30 Aug 2019

• By Michael Cipriano

Although only a few companies commented on the FDA's draft guidance on the benefit/risk assessment of new opioids, they cut against conventional wisdom by supporting the agency's desire to see active comparator data.

Box fighters trainning outdoor . Mixed media — Sponsors seem onboard with pitting new opioids against active comparators.

The US Food and Drug Administration has conveyed its desire to see future new drug applications for opioids demonstrate a comparative advantage over existing analgesics, and the agency is getting some public support from sponsors.

Although companies commenting on the FDA's June 2019 draft guidance on the benefit/risk assessment framework for opioids raised a variety...