AcelRx announces DSUVIA™ Receives FDA approval

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in a medically supervised setting, announced today the approval of DSUVIA™ by the U.S. Food and Drug Administration (FDA). DSUVIA is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments.

“The FDA approval of DSUVIA is the culmination of nearly 15 years of research to improve the standard of care for managing acute pain in medically supervised settings,” said Dr. Pamela Palmer, Co-Founder and Chief Medical Officer, AcelRx. “As an anesthesiologist, I’ve seen the challenges that IV opioids pose to patients and providers, such as logistical delays in initiating IV lines, difficulty in accessing veins, and medication errors with injectable opioids. AcelRx was founded to develop a simple, effective, non-invasive analgesic option to enable healthcare professionals to rapidly manage their patients’ acute pain.”

DSUVIA is a 30 microgram (mcg) sufentanil tablet in a single-dose, pre-filled applicator for under the tongue (sublingual) administration by a healthcare professional only in certified medically supervised settings. In a randomized, double-blind, placebo-controlled clinical study, DSUVIA demonstrated a statistically greater summed pain intensity difference from baseline over the first 12 hours of the study (SPID12) compared to placebo. The pain intensity difference from baseline was superior to that of the placebo group within 15 minutes and median meaningful pain relief occurred following a single dose. The single-strength tablet and single-unit packaging are designed to mitigate the possibility of dosing errors, misuse and diversion. The sublingual administration makes DSUVIA an option for patients with nothing by mouth (NPO) status and patients with difficult IV access (obese, elderly, burn or needle-phobic patients). Avoiding an IV has the potential to offer efficiency improvements in healthcare settings and improve patient experience. There are an estimated 92 million annual adult patient visits to medically supervised settings for moderate-to-severe acute pain. An estimated 51 million of these visits are to emergency departments (ED), with an estimated 18 million of these ED patients receiving an IV only for pain management.1

“Managing acute pain is critical to a patient’s recovery process, especially in the postoperative setting, but current oral and IV opioid analgesics can be slow-acting and challenging to dose and administer, which in turn can limit optimal pain relief and even be dangerous to patients,” said Dr. David Leiman, Clinical Assistant Professor of Surgery, University of Texas at Houston and Director of HD Research. “As a single-dose, non-invasive medication with a rapid reduction in pain intensity, DSUVIA represents an important alternative for healthcare providers to offer patients for acute pain management.”

“The approval of DSUVIA, which was developed in collaboration with the Department of Defense, underscores our commitment to provide innovative therapies for use in medically supervised settings,” said Vince Angotti, Chief Executive Officer, AcelRx. “We believe the unique features of DSUVIA are an important leap forward in the management of acute pain and patient care in these settings. We are committed to the safe and effective administration of DSUVIA through diligent adherence to our FDA-approved Risk Evaluation and Mitigation Strategies program.”

The DSUVIA commercial launch is expected in the first quarter of 2019.



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