AcelRx Announces 2020 Year End Metrics and Review of 2020 Achievements
REDWOOD CITY, California, January 14, 2021 / PRNewswire / – AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced preliminary unaudited financial results and other information related to its participation in investor presentations, meetings and events during the week of 39e JP Morgan Healthcare Annual Conference. The Company will post its revised corporate presentation in the investors section of its website.
Highlights of 2020
- DSUVIA® has received Department of Defense (DoD) Stage C approval, a decision that approves the use of DSUVIA in all U.S. Army Assemblies, Kits, and Outfits (SKOs). Initial storage orders have started for US Army SKOs and are expected to move closer $ 30 million over the next three years, depending on troop deployment schedules.
- In March, AcelRx announced an agreement with Brigham and Women’s Hospital for an investigator-initiated study on DSUVIA led by Richard D. Urman MD, MBA, Associate Professor of Anesthesia and Co-Director of the Perioperative Research Center at Brigham and Women’s Hospital and Harvard School of Medicine. This study is ongoing and evaluates 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 commercialize DSUVIA in the dental and oral surgery markets in United States exclusively through the dental division of Zimmer Biomet. The official launch is scheduled for 2021, once Zimmer Biomet receives the necessary licenses. The estimated applicable market for dental surgeries is over 7 million procedures annually.
- In August, AcelRx announced the publication of a study titled “Reduction of Opioid Use and Reduction of Time Spent in the Post-Anesthesia Unit Following Preoperative Administration of Sublingual Sufentanil in an Outpatient Surgery Setting” by Christian Tvetenstrand, MD and Michael wolff, MD, in the Journal of Clinical Anesthesia and Pain Management (Tvetenstrand and Wolff study). Highlights of the publication included an overall reduction of more than 50% in opioids administered perioperatively and a 34% reduction in post-anesthetic care unit (PACU) time in patients treated with DSUVIA compared to historical controls. See the section on warnings below.
- In August, AcelRx announced an investigator-initiated study with the Cleveland Clinic evaluating the effects of DSUVIA on postoperative recovery from orthopedic surgery. This double-blind study is ongoing and compares DSUVIA with IV fentanyl in patients undergoing knee arthroscopy.
- In September, AcelRx announced that the US military’s access to DSUVIA had been expanded with the addition of DSUVIA to the DoD Joint Deployment Form.
- In September, the US military awarded AcelRx a contract of up to $ 3.6 million over four years for the purchase of DSUVIA to support a DoD study to assist in the development of clinical practice guidelines.
- In December, AcelRx announced the publication of clinical data in an article in the Universal Surgery Journal titled “A Medication Use Evaluation of Sufentanil Sublingual Tablet 30 mcg for the Perioperative Management of Surgical Pain”, by the lead author Koth cassavaugh, PharmD, Director of Pharmacy (Cassavaugh Review), who reported that perioperative dosing of DSUVIA may provide faster recovery times from PACU compared to standard IV opioid administration. In addition, patients in the control group received a 66% higher mean intraoperative IV opioid dose than patients receiving DSUVIA and postoperative opioid use for the DSUVIA group was less than half of the control IV opioid group, orthopedic surgery patients with the greatest decrease (69%). See the section on warnings below.
- Obtained 348 form approvals through the end of 2020, a significant achievement in one year with restrictions and delays related to COVID.
- Preliminary unaudited revenue for the 2020 fiscal year approximately $ 5.4 million.
- Preliminary December 31, 2020 the balance of cash, cash equivalents and short-term investments was $ 42.9 million.
“I am satisfied with the business execution of our team during these difficult times,” said Vince angotti, CEO of AcelRx. “We expect new real data to support DSUVIA’s value proposition as an alternative to IV opioids, and we continue to make solid progress on all four pillars of our revenue plan. I look forward to hearing from you. provide further updates during our year-end revenue call. “
The above information concerned the expected operating results of the company for the financial year ended and as of December 31, 2020, including income and cash, cash equivalents and short-term investments, is preliminary, has not been audited and is subject to change upon completion of the audit of the financial statements of the company on the date and for the year ended December 31, 2020.
About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA®, known as DZUVEO ™ in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified healthcare facilities under medical supervision, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic , and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia by a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a solid single strength dosage form administered sublingually via a single dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid pain reliever previously marketed only for intravenous and epidural anesthesia and analgesia. The pharmacokinetic profile of sufentanil administered sublingually avoids the high peak plasma concentrations and short duration of action seen with IV administration. The European Commission has approved the marketing of DZUVEO in Europe in June 2018 and the company is currently in talks with potential European marketing partners. This press release is intended for investors only. For more information, including important safety information and a black box warning for DSUVIA, please visit www.DSUVIA.com.
About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx’s non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. AcelRx has one product approved in the United States, DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO ™ in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic in adult patients in certified healthcare facilities under medical supervision, and a product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the United States, is under development as a patient-controlled analgesia (PCA) system innovatively designed to reduce pain acute moderate to severe in settings under medical supervision. DZUVEO and Zalviso are both approved products in Europe. For more information on AcelRx, please visit www.acelrx.com.
Tvetenstrand and Wolff study
The study compared a prospective group of patients receiving preoperative dosing of a single sublingual tablet of DSUVIA with 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. Limitations of the study include the fact that it was an open study, the retrospective nature of the control group, and the focus only on general surgery patients. AcelRx did not fund the Tvetenstrand and Wolff study, but did fund medical writing support. Dr Tvetenstrand is a paid consultant to AcelRx.
The evaluation focused on 140 patients who received one dose of DSUVIA compared to 158 patients who had received traditional IV opioids during the same period undergoing the same surgical procedures. The limitations of the study included that it was a retrospective, single-center study of DSUVIA dosing in a surgical patient population and that inpatient and outpatient surgery data were combined. The study did not control whether patients were opioid-naïve or opioid tolerant in the treatment groups, however, there is no reason why these patients were present at a significantly higher frequency in one. either of the groups. AcelRx did not provide funding for the conduct of the assessment, but funded medical writing support. Dr Cassavaugh is a paid consultant to AcelRx.
This press release contains forward-looking statements, including, but not limited to, statements relating to income and cash, cash equivalents and short-term investments AcelRx expects to issue for fiscal 2020 on timing of DSUVIA acquisition by the military, timing of official launch by Zimmer Biomet, and expectations for other real-world data to support DSUVIA’s value proposition as an alternative to IV opioids. These and all other forward-looking statements are made in accordance with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terms such as “believes”, “expects “”. anticipate, “may”, “will”, “should”, “seek”, “approximately”, “hear”, “foresee”, “estimate” or the negative of these or other comparable words. 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, these 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 provided with the Securities and Exchange Commission ( SEC) .You are warned not to s place undue reliance on these forward-looking statements, which speak only as of the date on which such statements were first made. Except to the extent required by law, AcelRx assumes no obligation to publicly disclose the result of any revision of these forward-looking statements to reflect events or circumstances subsequent to the date hereof, or to reflect the occurrence of unforeseen events. .
SOURCE AcelRx Pharmaceuticals, Inc.