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AcelRx Announces Year-End 2020 Metrics and Review of 2020 Achievements
Key Highlights of 2020
- DSUVIA® achieved Milestone C approval from the
Department of Defense( DoD), a decision that approves DSUVIA for use in all U.S. Armysets, kits and outfits (SKOs). Initial stocking orders have begun for U.S. ArmySKOs and are expected to approximate $30 millionover the next three years, dependent on troop deployment schedules.
- In March, AcelRx announced an agreement with
Brigham and Women's Hospitalfor an investigator-initiated study of DSUVIA led by Richard D. UrmanMD, MBA, Associate Professor of Anesthesia and co-director of the Center for Perioperative Researchat Brigham and Women's Hospitaland Harvard Medical School. This study is ongoing and is evaluating the perioperative use of DSUVIA in patients undergoing spine surgery compared to their standard intravenous (IV) opioid regimen.
- In July, AcelRx entered into a distribution agreement with Zimmer Biomet to market DSUVIA within the dental and oral surgery markets in
the United Statesexclusively through Zimmer Biomet's Dental division. The formal launch is planned in 2021, once Zimmer Biomet receives necessary licenses. The estimated applicable market in dental surgeries is over 7 million annual procedures.
- In August, AcelRx announced the publication of a study entitled, "Reduced Opioid Use and Reduced Time in the
Postanesthesia Care Unit Following Preoperative Administration of Sublingual Sufentanilin an Ambulatory Surgery Setting," by Christian Tvetenstrand, MD and Michael Wolff, MD, in the Journal of Clinical Anesthesiaand Pain Management(Tvetenstrand and Wolff Study). Highlights of the publication included a greater than 50% overall reduction in opioids administered perioperatively and a 34% reduction in postanesthesia care unit (PACU) time in the DSUVIA-treated patients compared to historical controls. See Cautionary Statements section below.
- In August, AcelRx announced an investigator-initiated study with
Cleveland Clinicevaluating the effects of DSUVIA on post-operative recovery from orthopedic surgery. This double-blind study is ongoing and compares DSUVIA to IV fentanyl for patients undergoing knee arthroscopy.
- In September, AcelRx announced that the
U.S.military's access to DSUVIA was expanded with the addition of DSUVIA to the DoD Joint Deployment Formulary.
- In September, the
U.S. Armyawarded AcelRx a contract of up to $3.6 millionover four years for the purchase of DSUVIA to support a DoDstudy to aid the development of clinical practice guidelines.
- In December, AcelRx announced the publication of clinical data in an article in the
Journal of Universal Surgeryentitled, "A Medication Use Evaluation of Sufentanil Sublingual Tablet 30 mcg for the Perioperative Management of Surgical Pain," by lead author Koth Cassavaugh, PharmD, Director of Pharmacy (the Cassavaugh Evaluation), which reported that perioperative dosing of DSUVIA can provide more rapid PACU recovery times compared to standard IV opioid administration. In addition, patients in the control group received 66% higher mean dosing of intraoperative IV opioids compared to patients receiving DSUVIA and postoperative opioid use for the DSUVIA group was less than half of the control IV opioid group, with orthopedic surgery patients having the largest decrease (69%). See Cautionary Statements section below.
- Achieved 348 formulary approvals through the close of 2020, a significant achievement in a year with COVID-related restrictions and delays.
- Preliminary unaudited FY 2020 revenues approximated
December 31, 2020cash, cash equivalents and short-term investments balance was $42.9 million.
"I'm pleased with our team's commercial execution during these challenging times," said
The information above related to the Company's expected operating results for the year ended and as of
About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA®, known as DZUVEO™ in
Tvetenstrand and Wolff Study
The study compared a prospective group of patients with preoperative dosing of a single sublingual DSUVIA tablet to a historical control group receiving standard intravenous (IV) opioid administration for same-day general surgery procedures. A total of 127 patients were evaluated in the study. Study limitations include that it was an open-label study, the retrospective nature of the control group, and the focus on only general surgery patients. AcelRx did not provide funding for the conduct of the Tvetenstrand and Wolff Study but did fund medical writing support.
The evaluation focused on 140 patients who were dosed with DSUVIA compared to 158 patients who had been dosed with traditional IV opioids during the same time period undergoing the same surgical procedures. Study limitations included that it was a single-center, retrospective study of DSUVIA dosing in a surgical patient population and both inpatient and outpatient surgery data was combined. The study did not control for whether patients were opiate naïve or opiate tolerant in the treatment groups, however, there is no reason for these patients to be present at a substantially higher frequency in either group. AcelRx did not provide funding for the conduct of the evaluation but did fund medical writing support. Dr. Cassavaugh is a paid consultant of AcelRx.
This press release contains forward-looking statements, including, but not limited to, statements related to revenues and cash, cash equivalents and short-term investments AcelRx expects to report for fiscal year 2020, the timing of the procurement of DSUVIA by the military, the timing of the formal launch by Zimmer Biomet, and expectations for further real-world data to support the value proposition of DSUVIA as an alternative to IV opioids. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believes," "expects," "anticipates," "may," "will," "should," "seeks," "approximately," "intends," "plans," "estimates," or the negative of these words or other comparable terminology. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements. In addition, such risks and uncertainties may include, but are not limited to, those described in AcelRx's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the
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Investor Contacts: Raffi Asadorian, CFO, AcelRx, firstname.lastname@example.org; or Brian Korb, Solebury Trout, 646-378-2923, email@example.com