Acelrx Pharmaceuticals Inc (ACRX) SEC Filing 10-Q Quarterly report for the period ending Tuesday, March 31, 2020

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DSUVIA achieved Milestone C approval from the Department of Defense, a decision that approves DSUVIA for use in all U.S. Army sets, kits and outfits (SKOs) with an expectation of expanded use across all branches of the military and the potential for use across additional federal and state agencies. AcelRx expects that initial stocking orders beginning later this year for U.S. Army SKOs alone will approximate $30 million over the next three years based on troop deployment schedules.

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Prior to the impact from the COVID-19 pandemic, AcelRx was on pace to exceed formulary approvals and REMS-certified facilities goals for 2020. Following the initial impact of COVID, as of April 30, 2020, 221 healthcare facilities are now REMS-certified and able to purchase DSUVIA and 223 formulary approvals have been achieved. As previously communicated, in response to the COVID-19 pandemic, hospitals and ambulatory surgery centers have restricted in-person meetings with pharmaceutical company personnel. Accordingly, year-end 2020 REMS-certified facilities and formulary approvals goals will be re-evaluated once COVID-19 restrictions are lifted and there is greater visibility into healthcare facility access.

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Expect the publication of two hospital studies of real-world data of DSUVIA in the perioperative setting which analyze DSUVIA’s impact on IV opioid requirements in the post-anesthesia care unit (PACU) and discharge time from the PACU in the coming months.

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Announced an agreement with Brigham and Women's Hospital for an investigator-initiated study of DSUVIA led by Richard D. Urman MD, MBA, Associate Professor of Anesthesia and co-director of the Center for Perioperative Research at Brigham and Women's Hospital and Harvard Medical School. The study plans to examine the perioperative use of DSUVIA in the analgesic regimen for spine surgery.