Zalviso EU

Zalviso® (in EU)
  • Pre-Clinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Submitted MAA
  • Approved

 

Moderate-to-Severe Acute Pain in a Hospital Setting

Zalviso is to be administered in a hospital setting only and should only be prescribed by physicians who are experienced in the management of opioid therapy. Zalviso sublingual tablets are to be self-administered by the patient in response to pain using the Zalviso administration device. Zalviso should not be used in patients with hypersensitivity to the active substance or with significant respiratory depression. The marketing authorization is granted for the 28 EU member states as well as for the European Economic Area (EEA) countries, Norway, Iceland and Liechtenstein.

For a complete summary of the product characteristics, please visit the EMA Website.


Zalviso Commercial Status

Grünenthal Group GmbH, AcelRx's licensee in Europe and Australia, began its pilot launch of Zalviso in April 2016 to hospitals in Germany. Based on their success with this initial launch program, Grünenthal initiated the sale of Zalviso in France, the United Kingdom, Netherlands, Italy and Belgium in the second quarter of 2016 followed by Ireland and Portugal later in the year. Additional European countries will be added to the Grünenthal launch program throughout 2017 and following.

In the United States and other geographies, Zalviso remains an investigational product. To review results of the clinical studies, which were conducted on the U.S. and formed the basis of the Marketing Authorization Application (MAA) that AcelRx submitted to Europe’s EMA in 2014, please visit the Zalviso-U.S. webpage by clicking here.

Moderate-to-Severe Acute Pain in a Hospital Setting

Moderate-to-severe acute pain management in the hospital remains a challenge for healthcare providers with up to 75% of patients reporting inadequate pain relief following surgery.1 Approximately 12 million surgical procedures per year result in moderate-to-severe acute pain in the U.S.,2 with an additional 7.4 million hospital inpatients in the U.S. annually experiencing moderate-to-severe acute pain from other, non-post-surgical, medical conditions.3

Inadequate treatment of moderate-to-severe acute pain can lead to decreased mobility, which increases the risks for serious medical complications, including deep vein thrombosis and partial atelectasis (lung collapse), potentially resulting in extended hospital stays.4

Potential Zalviso Benefits

Zalviso is a drug/device combination product designed to deliver 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.5

Zalviso has the potential to address several key disadvantages of IV PCA, including:

  • Lowering the risk of infections related to IV access; Zalviso is non-invasive
  • Enhancing ease of mobility; Zalviso does not tether the patient
  • Lowering the risk of pump programming errors; Zalviso is pre-programmed

Zalviso is designed to provide a favorable safety, efficacy and tolerability profile, potentially enabling Zalviso to become a strong treatment option for patient-controlled analgesia.

 

  1. Apfelbaum JL, et al. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-40.
  2. In-house commissioned market research. Rosetta "AcleRx ARX-01 Market Assessment" January 2012.
  3. Hefland, M and Freeman, M. Assessment and management of acute pain in adult medical inpatients: a systematic review. Pain Medicine. 2009; 10 (7) 1183-1199
  4. Overdyk FJ, DeVita MA, Pasero C. Postoperative opioid-induced respiratory depression: current challenges and new developments in patient monitoring. Anesthes News. 2012;1-8.
  5. Mather LE,. Opioids: a pharmacologist’s delight! Clin Exp Pharmacol Physiol 1995; 22:833-6