AcelRx Pharmaceuticals (NASDAQ:ACRX) will likely be under pressure following the release of briefing materials for Thursday's FDA advisory committee meeting to review and discuss its marketing application seeking approval for DSUVIA (sufentanil sublingual tablet) for the management of moderate-to-severe acute pain severe enough to requires an opioid analgesic and for which alternative treatments are inadequate.
On page 29 on the FDA document, the review team states that the Human Factors Study did not demonstrate that the user interface "supports the safe and effective use of the product" and "we do not find the risk acceptable." They recommend changes to the user interface and another human factors study to show the effectiveness of the recommended mitigation strategies.
Update: Shares are down 5% premarket on light volume.
Update: Shares are now down 51% premarket.
Update: The FDA review team states that the company's resubmitted data supports the safe and effective use of the product for its intended use (page 41). It also agrees with the company's proposed risk evaluation and mitigation strategy (REMS) contingent on a healthcare provider administering the dose. The safety concerns cited previously were related to the company's first filing. Shares are now down 17% premarket.
Update: Shares are up 24% on a 10x surge in volume on investors' confidence of a thumbs up from the advisory committee.
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