AcelRx Pharmaceuticals Announces Commentary in Practical Pain Management on Previously Published Clinical Data on Preoperative Administration of DSUVIA®

Rhea-AI Summary

AcelRx Pharmaceuticals (NASDAQ: ACRX) announced the publication of a commentary in Practical Pain Management discussing the benefits of DSUVIA for acute pain management. The commentary, authored by three pharmacy thought-leaders, highlights a study indicating that preoperative DSUVIA administration led to faster discharge from the post-anesthesia care unit and reduced opioid use by over 50%. DSUVIA is designed for use in medically supervised settings and has FDA approval since November 2018. The company is actively seeking European marketing partners for its product.

Positive

• Publication of a peer-reviewed commentary supporting DSUVIA's use in acute pain management.
• Study indicates DSUVIA leads to 34% faster PACU discharge compared to standard IV opioids.
• Over 50% reduction in opioid utilization with DSUVIA during the perioperative period.
• Potential for DSUVIA to address opioid stewardship concerns.

Negative

• Study limitations include open-label design and retrospective nature of the control group.

REDWOOD CITY, Calif., Nov. 18, 2020 /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 the recent publication by Practical Pain Management of a commentary discussing the benefits of using DSUVIA for acute pain management.

The commentary is by three national thought-leaders in the field of pharmacy, Dr. Jeffrey Fudin, Dr. Jeffrey Bettinger and Dr. Joseph Dasta, and reviews a study entitled "Reduced Opioid Use and Reduced Time in the Postanesthesia Care Unit Following Preoperative Administration of Sublingual Sufentanil in an Ambulatory Surgery Setting" by Christian Tvetenstrand, MD and Michael Wolff, MD. This study was previously published in the Journal of Clinical Anesthesia and Pain Management, which the company announced in August 2020.

"We are pleased with the post-approval data and the peer-reviewed commentary that continue to illustrate physiologic and economic rationales for DSUVIA's use in acute pain management in medically supervised settings," said Dr. Pamela Palmer, AcelRx Chief Medical Officer and co-founder. "With an increasing focus on opioid stewardship, DSUVIA is well-suited to effectively manage acute pain while demonstrating in this study the ability to reduce the overall exposure to opioids and contribute to the reduced cost of patient care."

The Tvetenstrand and Wolff 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, with the following key findings:

• Discharge from the PACU occurred 34% faster than control group.
  
  
• Significantly fewer DSUVIA-treated patients required intraoperative IV opioids following preoperative dosing with DSUVIA compared with the control group.
  
  
• DSUVIA patients received a significantly lower preoperative and intraoperative mean opioid dose relative to control group.
  
  
• Fewer DSUVIA-treated patients required any postoperative opioid with overall opioid utilization being reduced by over 50% with DSUVIA use throughout the perioperative setting.
  
  
• Significantly fewer patients in the DSUVIA group received adrenergic agonists for hemodynamic instability and IV acetaminophen for pain.
  
  
• Overall, the preoperative administration of DSUVIA resulted in significant reductions in opioid use during outpatient surgery and facilitated shorter PACU stays.

Limitations of the Tvetenstrand and Wolff study 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. AcelRx did not provide any compensation to the authors for the commentary.  Drs. Tvetenstrand, Fudin and Dasta are paid consultants of AcelRx.

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 medically supervised healthcare settings, 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 via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia.

The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and the Company is currently in discussions with potential European marketing partners. This release is intended for investors only. For more information, including important safety information and 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 proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. AcelRx has one approved product in the U.S., 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 for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso^® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.  For additional information about AcelRx, please visit www.acelrx.com.

 

 

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SOURCE AcelRx Pharmaceuticals, Inc.

FAQ

What are the key findings from the DSUVIA study published on November 18, 2020?

The study found that patients receiving preoperative DSUVIA had a 34% faster discharge from the PACU and over 50% reduction in opioid use compared to those receiving standard IV opioids.

What is DSUVIA and when was it approved?

DSUVIA, a sufentanil sublingual tablet, was approved by the FDA in November 2018 for managing acute pain in medically supervised settings.

Who authored the commentary discussing DSUVIA in Practical Pain Management?

The commentary was authored by Dr. Jeffrey Fudin, Dr. Jeffrey Bettinger, and Dr. Joseph Dasta.

What is the significance of the DSUVIA study for opioid stewardship?

The study underscores DSUVIA's potential to effectively manage acute pain while reducing overall opioid consumption, which is critical in the context of rising opioid stewardship initiatives.