AcelRx Provides Guidance On 2017 Milestones For ARX-04 In U.S.

(RTTNews) - AcelRx Pharmaceuticals, Inc. (ACRX) provided guidance on 2017 milestones for its lead product, ARX-04, known as DSUVIA (sufentanil sublingual tablet, 30 mcg) in the United States.

AcelRx submitted a 505(b)2 new drug application (NDA) for DSUVIA for moderate-to-severe acute pain in a medically supervised setting on December 12, 2016. The U.S. Food and Drug Administration (FDA) has 60 days to review an application and determine whether the NDA is acceptable for filing. AcelRx expects to receive this notification from the FDA in the first quarter of 2017. Assuming the FDA, through the Division of Anesthesia, Analgesia and Addiction Products (Division), accepts the NDA for filing, AcelRx will liaise with the Division and any advisory committees that may be convened during the review period.

Should the Division favorably complete its review by the expected Prescription Drug User Fee Act (PDUFA) date, AcelRx anticipates being prepared to begin commercialization of DSUVIA as early as the fourth quarter of 2017.

Tim Morris, CFO of AcelRx added, "We ended 2016 with $80 million in cash and cash equivalents. We anticipate having about $50 million in cash at the end of the 2nd quarter of 2017. Our spending in the 2nd half of 2017 will depend on the review process and PDUFA date set by the Division as well as the specific details of our commercial plans. The acceptance of the NDA for DSUVIA by April 1, 2017 also will allow us to refinance the $21 million outstanding debt with Hercules."