ARX04 (known as DSUVIA™ in the U.S.)

EU Regulatory Status at a Glance:
  • Pre-Clinical
  • Phase 1
  • Phase 2
  • Phase 3
  • MAA Filed
  • Approved

 

Moderate-to-Severe Acute Pain in Medically Supervised Settings

In situations of trauma or injury, it is advantageous to have a rapid-acting, non-invasive method for treating acute pain. In the battlefield, emergency medicine and ambulatory care environments, patients may not have immediate intravenous (IV) access available. Intramuscular (IM) injections are the current standard of care on the battlefield11, but they are invasive, painful, and have been rated less effective than IV opioids at providing fast pain relief.2 In cases of severe trauma where the patient is often in hypovolemic shock and muscles are not well perfused, pain medication given by intramuscular injection may not readily reach the blood stream to provide pain relief, rendering this route of delivery suboptimal.3 Additionally, IV dosing results in high peak plasma levels, thereby limiting the amount of opioid that can be used at once, and requiring frequent re-dosing to titrate to satisfactory analgesia. Moreover, oral pills and liquids have generally shown slower and more erratic onset of analgesia in comparison to IV administration.4

ARX-04 Potential Settings of Use

ARX-04 (sufentanil sublingual tablet, 30 mcg) is an investigational product candidate consisting of 30 mcg sufentanil in very small sublingually absorbed tablets that are delivered via a disposable, pre-filled, single-dose applicator (SDA). AcelRx is developing ARX-04 in Europe for the management of moderate-to-severe acute pain in a variety of medically supervised settings, including in emergency medicine, outpatient or ambulatory surgery, non-surgical patients experiencing pain in the hospital, or post-operative patients, following short-stay surgery, who do not require more long-term analgesia.

ARX-04 European Market Opportunity

In Europe, the ARX-04 market is expected to be comprised of approximately 142 million adults who experience pain following surgery in hospitals and ambulatory surgery centers, as well as those treated by ambulance services or in emergency departments.5Each year there are an estimated 110 million encounters in the emergency department6and 32 million in-patient and out-patient surgeries5 performed in Europe. Of those, it is anticipated that 51 million patients in emergency medicine and 16 million post-operative patients experience moderate-to-severe acute pain.5 Using the published priced benchmarks of Penthrox (methoxyflurane) and branded fentanyl products, £17.89 (UK) and €8.04 (Germany), respectively, we believe that ARX-04 could achieve a €15 price per unit.5Therefore, AcelRx believes ARX-04 could reach peak sales of €500 million.5

Current Development Status

AcelRx filed a New Drug Application with the U.S. Food and Drug Administration (FDA) for DSUVIA in the U.S. for the treatment of moderate-to-severe acute pain in medically supervised settings in December 2016. In March 2017 AcelRx filed a Marketing Authorization Application (MAA) under the centralized procedure for ARX-04 in the EU based on DSUVIA clinical studies; the MAA is currently under review at the European Medicines Agency (EMA).

For information on DSUVIA’s development in the U.S., including a review of clinical studies, please click here.

 

  1. Gandy J. Ketamine in Tactical Combat Casualty Care. Defense Health Board Decision Briefing, Trauma and Injury Subcommittee, February 2012
  2. Thomas, SL and Shewakramani, S. Prehospital Trauma Analgesia. Journal of Emergency Medicine 2008; 35(1): 47-57
  3. de Moya, M. A. Shock. In Merck manual online, professional version. Retrieved from (link)
  4. Cashman, J. Routes of Administration. In Macintyre, P.E., Rowbotham, D.J., and Walker, S.M., Clinical Pain Management Second Edition: Acute Pain, Volume 1 (pp. 205). Taylor & Francis Group, LLC, Oct 26, 2012
  5. Data on File. In-house commissioned market research. Quintiles® “ARX04: Asset forecast for Europe” Study dated May 3, 2016
  6. Guéant, S, et al. Quality of Pain Management in the Emergency Department: Results of a Multicentre Prospective Study. European Journal of Anaesthesiology 2011; 28(2): 97–105