AcelRx is currently focused on the development of ARX-04 and Zalviso®, both of which are based on the Company's proprietary sublingual formulation technology. ARX-04 and Zalviso® are completing Phase 3 clinical testing with new drug applications expected to be submitted in 2016.

ARX-04 (in US)
  • Pre-Clinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Approved
ARX-04 (in EU)
  • Pre-Clinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Approved
Zalviso® (in EU)
  • Pre-Clinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Approved
Zalviso® (in US)
  • Pre-Clinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Approved

 

ARX-04 (sufentanil sublingual tablet, 30 mcg)

ARX-04 is designed to provide a non-invasive treatment option for patients with moderate-to-severe acute pain, in multiple medically supervised settings ranging from the battlefield, civilian emergency departments, ambulatory surgery centers, physician's offices and hospitals. In September 2015, AcelRx reported that ARX-04 met primary and secondary endpoints in a multi-center, double-blind, placebo-controlled Phase 3 trial (SAP301) in patients with moderate-to-severe acute pain following ambulatory abdominal surgery.

ARX-04 is also being assessed in an open-label Phase 3 study (SAP302) in adult patients who present to the emergency room with moderate-to-severe acute pain associated with trauma or injury. The study is expected to be completed in early 2016. A third Phase 3 study (SAP303) is ongoing in postoperative patients with moderate-to-severe acute pain. This open-label study will focus on enrolling up to 100 adult patients from a wide variety of age groups and types of surgery.

Zalviso® (sufentanil sublingual tablet system)

Currently, patients experiencing moderate-to-severe acute pain in the hospital may have intravenous patient controlled analgesia (IV PCA), as an option to treat their pain, typically utilizing morphine or hydromorphone.1 However, the use of IV PCA has been associated with deficiencies that can negatively impact patient safety and recovery. These include: a) side effects from morphine or hydromorphone and their active metabolites;2 b) medication delivery errors typically related to misprogramming IV PCA pumps; and c) complications associated with IV delivery such as infection risk and decreased mobility potentially related to the invasive nature of IV delivery.3

Zalviso is designed to address these problems by delivering 15 mcg sufentanil, a high therapeutic index opioid, formulated in a proprietary non-invasive sublingual dosage form via a novel hand-held, pre-programmed, patient-controlled analgesia system.

Zalviso has completed three Phase 3 clinical trials: two placebo-controlled efficacy and safety trials and one open-label active comparator trial, in which Zalviso was compared to IV PCA morphine. Each of the three Phase 3 trials successfully achieved its primary endpoint. Based on FDA feedback, AcelRx is planning to conduct a fourth study in a diverse post-surgical population, which will further evaluate the overall performance of the Zalviso System.

 

  1. McKeen MJ, Quraishi SA. Clinical Review of Intravenous Opioids in Acute Care. J Anesthesiol Clin Sci 2013, 2:1     
  2. Smith, HS. Opioid Metabolism. Mayo Clin Proc. July 2009;84(7):613-624
  3. Lisi DM. Patient-Controlled Analgesia and the Older Patient. US Pharm. 2013;38(3):HS2-HS6