UPDATE: AcelRX Pharma Says 'We have successfully transitioned ARX-04 into late-stage development, defined the regulatory pathway for ARX-04 and Zalviso in the U.S.'

"In addition, AcelRx has revised its pipeline priorities for 2016 and has selected ARX-04, (30 mcg of sufentanil sublingual tablet), as its primary focus for clinical development and commercialization. AcelRx has also decided to postpone the start of the Zalviso Phase 3 trial (IAP312) originally planned for the first quarter of 2016 as we determined that our Zalviso commercial supplies provided the performance quality we expect to provide with our NDA resubmission and with an anticipated U.S. commercial launch. The Company considered recent testing comparing Zalviso clinical and commercial supplies and determined that commercial supplies may better optimize system functionalities for the conduct of IAP312. This testing focused on the healthcare professional initiation of the system during set-up and would not be expected to affect patient safety or dosing. The use of commercial supplies may also reduce review time for any potential post-approval changes with supply manufacturers and software updates. "Now that we have received the necessary approvals from the Department of Defense and have initiated the two remaining Phase 3 studies for ARX-04, we have reviewed our resource needs and will focus our clinical, regulatory and commercial teams primarily on ARX-04," stated Howie Rosen, CEO. Also, we were going to make the switch to commercial Zalviso supplies post-approval but by doing it now, we anticipate it will ultimately make the launch of Zalviso in the U.S. smoother." Mr. Rosen affirmed, "Zalviso remains an important product for AcelRx and we look forward to updating the market on its progress toward NDA resubmission." The Company confirms its corporate objective that, assuming successful completion of the ongoing ARX-04 Phase 3 studies (SAP302 and SAP303) by the third quarter of 2016, the Company anticipates submitting the NDA for ARX-04 in the fourth quarter of 2016."