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. Phase 3 clinical testing is complete for ARX-04 and a Phase 3 clinical trial (IAP312) has been initiated for Zalviso®. New drug applications are expected to be submitted in 2016 and 2017, respectively..

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, and hospitals.

The ARX-04 Phase 3 clinical program, which concluded in September 2016, assessed the investigational product in the treatment of moderate-to-severe acute pain in three Phase 3 trials:

  • SAP301, a multi-center, double-blind, placebo-controlled study in patients who had undergone ambulatory abdominal surgery;
  • SAP302, a multi-center, open-label study in adults who presented to an emergency room with trauma or injury; and
  • SAP303, a multi-center, open-label study in patients who had undergone short-stay in-hospital surgery.

In each of these Phase 3 clinical studies, ARX-04 has shown improvements in pain intensity as early as 15-to-30 minutes after the start of dosing, with most common adverse events including nausea, headache, dizziness, and vomiting. Efficacy and safety measures have thus far appeared consistent among age groups and comorbidities, such as hepatic impairment. In addition, SAP302 provided evidence that ARX-04 is not been associated with drug-induced cognitive impairment.

Results from SAP303 have been reported and a New Drug Application will be filed with the FDA by the end of 2016.

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 has initiated a fourth study (IAP312) in a diverse post-surgical population to 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