Grünenthal has issued notice to AcelRx Pharmaceuticals, Inc. to terminate the supply license agreement for Zalviso™, a drug-device combination product utilizing the opioid agonist sufentanil formulated in a proprietary sublingual tablet and delivered through a pre-programmed, non-invasive proprietary delivery device, for the management of acute moderate to severe post-operative pain1 in adult patients in Europe.
The decision to terminate the license agreement comes after careful consideration.
Terminating the supply of Zalviso™ is not related to any efficacy, safety or clinical concerns.
Further information will be provided directly to healthcare professionals in the coming weeks. We are working to ensure that patients and physicians feel supported during the termination process.
1. Zalviso - SUMMARY OF PRODUCT CHARACTERISTICS (SMPC). Available at: https://www.ema.europa.eu/en/documents/product-information/zalviso-epar-product-information_en.pdf