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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Dsuvia Gets Warning Letter As US FDA’s Opioid Decisions Complicate Commissioner Race
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.
Dsuvia: A Dull US FDA Review Preceded The Controversial Approval
US FDA's review of AcelRx's opioid Dsuvia did not presage the external fireworks that came following the approval.
Gottlieb Renews Call For New Opioid Review Paradigm As Democrats Prepare For House Control
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.