AcelRx Pharma's DSUVIA backed by FDA Ad Com
AcelRx Pharmaceuticals (ACRX) received the FDA Ad Com's backing by a 10-3 vote for its sufentanil sublingual tablet, DSUVIA, "for the management of moderate-to-severe pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate." The drug will probably be approved well before the November 3 PDUFA date. It has already been approved in the EU, and US approval will set the future for the small company in stone. The company supposedly already has a large order for the product from the US