Dsuvia's Thumbs Up From US FDA Advisory Panel Is First Positive Vote For An Opioid In 2018
AcelRx's sublingual opioid fills a need for narrow population, panelists conclude, despite US FDA's concerns about tablet size and committee's own worries about efficacy.
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US FDA's review of AcelRx's opioid Dsuvia did not presage the external fireworks that came following the approval.
Draft guidance says US FDA will consider product's benefit-risk balance relative to approved analgesics; it is particularly interested in comparative efficacy and safety data.
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