AcelRx's Sublingual Opioid Dsuvia Brings Unique Risk To Advisory Panel: Dropped Tablets
US FDA appears generally satisfied that AcelRx fulfilled initial safety concerns cited in October 2017 complete response letter.
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AcelRx oversimplified Dsuvia’s ease of use, Office of Prescription Drug Promotion says. Focus on opioid safety comes as critics of Janet Woodcock have pointed to FDA’s decisions in the space as disqualifying her for FDA commissioner. Letter appears to reflect long-standing FDA concerns: Dsuvia was approved with a REMS related to administration issues, and Xeris received a similar warning letter last year for exaggerating the ease of use of its glucagon pre-filled syringe Gvoke PFS.
US FDA's review of AcelRx's opioid Dsuvia did not presage the external fireworks that came following the approval.
US FDA's controversial approval of Dsuvia may prompt incoming House Democrats to pay special attention to commissioner's remarks on how agency reviews opioids.