Opioid Sponsors Enter 2019 At A Crossroads
Recent regulatory trends at US FDA offer no clear path to success for sponsors developing opioids. As 2018 concludes with only one approval and at least five rejections, firms will need new strategies if they hope to bring the
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A look back over FDA actions during the past 10 years shows the evolution of its policies on opioids, preemption, off-label promotion and use of real-world evidence.
Abuse-deterrent formulations have been polarizing in the opioid space; now the US FDA wants feedback on developing the formulations for central nervous system stimulants, such as ADHD drugs, which could renew debate about the value of the formulations and how the agency should weigh public health considerations when deciding whether to approve an individual product.
Legally, FDA can't require comparative effectiveness data for approval, but draft guidance notes that the agency really wants it; for sponsors, that leaves more questions than answers, mainly: What will FDA do with an opioid application that doesn't contain such data.