AcelRx falls after FDA staff says Dsuvia ‘offers no apparent advantage’

Shares of AcelRx (ACRX) are plunging in pre-market trading after the FDA posted the briefing documents for a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee to discuss the new drug application for Dsuvia submitted by AcelRx Pharmaceuticals for the management of moderate-to-severe acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adult patients in a medically supervised setting. In the document, FDA staff wrote: “Overall, although efficacy was demonstrated, Dsuvia offers no apparent advantage to currently available therapies. There are two areas of safety concern with this product that require further evaluation: the safety of Dsuvia in patients requiring the maximum dosing proposed for labeling because of the accumulation of sufentanil and the risk of misplaced tablets due to the small tablet size, use of an applicator, and inadequate directions for use. These concerns outweigh the possible benefit at this time.” In pre-market trading, AcelRx shares have fallen $1.03, or 39%, to $1.62.

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