European Commission (EC) Grants Marketing Authorization for Grünenthal's Zalviso® 15 Micrograms Sublingual Tablets for Treatment of Acute Moderate to Severe Post-operative Pain in Adult Patients

AACHEN, Germany, September 22, 2015 /PRNewswire/ --

• Zalviso^® is a new and innovative system that combines a drug and device to manage post-operative pain in a hospital setting 
• The pre-programmed, handheld system combines the benefits of patient-controlled analgesia with a non-invasive route of administration  
• In several European countries, Zalviso^® will be available in the first half of 2016 

The Grünenthal group announced today that the European Commission (EC) has approved Zalviso^® 15 micrograms sublingual tablets for the management of acute moderate to severe post-operative pain in adult patients. 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.

Zalviso^® is an innovative and effective system for use in hospitals offering several safety features for patients. It utilizes the opioid agonist sufentanil formulated in a proprietary sublingual tablet and delivered through an easy-to-use pre-programmed, non-invasive administration device.

Grünenthal holds the rights to commercialize Zalviso^® in Europe and Australia. The product will be available to Western European patients in the first half of 2016.

"We are delighted to bring a new, innovative way to manage post-operative pain to European healthcare professionals and patients," says Dott. Alberto Grua, Chief Commercial Officer Europe, Australia, North America & Global Product Supply (CCO EU, AUS NA & GPS) at Grünenthal. "By combining the benefits of patient-controlled analgesia with those of a non-invasive route of administration, Zalviso^® offers a unique solution to address unmet needs of adult patients suffering from acute moderate to severe post-operative pain."

On an annual basis, there are 19 million surgical procedures with associated acute moderate to severe post-operative pain in the European Union. A recent German survey in patients after surgery has shown that 55% of all patients are not satisfied with their treatment for post-operative pain^[1].30% even mention that their pain management has been inefficient^[1].

The Zalviso^® system allows strong, sustained and reliable pain relief with a fast onset of action similar to an intravenous application. In a Phase III clinical trial, Zalviso^® has proven to provide a superior method of pain control over a period of 48 hours (PGA 48) in a head-to-head comparison to PCA using intravenous morphine. According to patients, Zalviso^® provided a higher satisfaction with pain control and was considered easier to use enabling them to successfully manage their moderate to severe post-operative pain^[2].

The sublingual route of administration of sufentanil with the Zalviso^® system is a convenient method of application. Once the system has been set up, the patient can self-administer the sublingual tablet and adjust the dosing to individual analgesic needs for up to 72 hours, potentially reducing the need to involve healthcare professionals.

In addition, safety features such as a lock-out period and a patient ID thumb tag which is wirelessly paired to the administration device, make Zalviso^® a comparatively safe way to administer a strong opioid in a hospital setting.

In December 2013, Grünenthal in-licensed Zalviso^® from AcelRx Pharmaceuticals Inc. (Redwood City, CA, USA) for Europe and Australia. Grünenthal submitted a Marketing Authorization Application (MAA) for the medicinal product (Zalviso^® 15 micrograms sublingual tablets) to EMA in July 2014. In November 2014, AcelRx received the approval of the CE certificate for the Zalviso^® administration device after successful completion of the conformity assessment by the Notified Body BSI (British Standards Institute).

"The recent marketing authorization clearly shows our ability to successfully manage the complex European regulatory framework to bring hospital products to market that have been developed by one of our partners," adds Prof. Dr. Eric-Paul Pâques, CEO Grünenthal and Chairman of the Corporate Executive Board.

Dr. Pamela Palmer, MD, founder and Chief Medical Officer of AcelRx commented, "It is rewarding to know that patients in Europe soon will be able to benefit from the efficacy and safety of Zalviso^® to treat their moderate to severe pain after surgery. Patient-controlled analgesia benefits both patients and healthcare systems alike, and our clinical studies demonstrate the multiple advantages of sublingual sufentanil in this patient population."

About Zalviso^® 

Zalviso^® is an innovative, pre-programmed, non-invasive, handheld system that allows hospital patients with acute moderate to severe post-operative pain to self-dose with sufentanil sublingual tablets to manage their pain. It allows a strong, sustained and reliable pain relief with a fast onset of action. The sublingual application of sufentanil with the Zalviso^® system represents a convenient, comparatively safe and efficient route of administration that is easy to set-up and use. It is designed to optimize post-operative analgesia and to avoid some of the issues associated with the current systems for patient-controlled analgesia (PCA). Such issues include the invasive IV route of delivery of current PCA systems, the complexity of infusion pumps and the relatively high incidence of side effects of orally administered opioids and have been shown to potentially result in harm to patients. Grünenthal holds the rights for Zalviso^® in Europe and Australia while AcelRx retains all rights in North America, Asia, Latin America and Middle East/Africa.

About Grünenthal 

The Grünenthal Group is an independent, family-owned, international research-based pharmaceutical company headquartered in Aachen, Germany. We are an entrepreneurial specialist delivering true benefits to patients. By sustainably investing in research and development above the industrial average, we are committing to innovation in order to treat unmet medical needs and bring value-adding products to markets. Grünenthal is a fully integrated research & development company with a long track record of bringing innovative pain treatments and state-of-the-art technologies to patients.

Altogether, the Grünenthal Group is present in 32 countries with affiliates in Europe, Australia, Latin America and the US. Grünenthal products are sold in more than 155 countries and approx. 5,200 employees are working for the Grünenthal Group worldwide. In 2014, Grünenthal achieved revenues of € 1.154 bn. More information: http://www.grunenthal.com.

^[1] Maier C et al. Dtsch Ärztebl Int. 2010; 107; 607-614

^[2] Melson T et al, Pain Practice. 2014; 14:679-88

Contact: Fabia Kehren, Corporate Communications, Tel.: +49-241-569-1616, Fabia.kehren@grunenthal.com

Grünenthal GmbH, 52099 Aachen, Germany, http://www.grunenthal.com