Grünenthal's Zalviso® 15 Micrograms Sublingual Tablets Receives Positive CHMP Opinion in the EU for Treatment of Acute Moderate to Severe Post-operative Pain in Adult Patients

AACHEN, Germany, July 24, 2015 /PRNewswire/ --

• Positive CHMP opinion marks a key milestone towards availability in the EU 
• Once approved, Zalviso^® represents a new system for patients to self-administer sublingual sufentanil after surgery 

The Grünenthal Group announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the marketing authorization of sufentanil sublingual tablets for the management of acute moderate to severe post-operative pain in adult patients. The Zalviso^® system, in-licensed from AcelRx Pharmaceuticals Inc., is an innovative drug-device combination 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.

The CHMP's positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). Once approved, the centralized marketing authorization will cover 28 EU member states which will also be valid in Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA).

On an annual basis, there are 19 million surgical procedures with associated moderate to severe pain in the European Union. Management of acute post-operative pain remains a key challenge.

"With Zalviso^®, Grünenthal has the opportunity to strengthen its hospital franchise and to expand its existing portfolio of innovative drugs for the treatment of moderate to severe pain. It will play a key role in further establishing Grünenthal as a major player in the European hospital market of centrally acting analgesics (CAA)", Dott. Alberto Grua, Chief Commercial Officer Europe, Australia, North America & Global Product Supply (CCO EU, AUS NA & GPS) from Grünenthal underlined.

"We are an entrepreneurial specialist with long-time experience in the field of pain. The recommendation of the CHMP supports our dedicated efforts to bring true innovation and benefits to pain patients. Another exciting example for our ambition is our recent announcement on the partnership with Proteus S.A., Chile, and Boston Children's Hospital, USA, for neosaxitoxin, a novel anesthetic for local anesthesia and post-operative pain management," adds Prof. Dr. Eric-Paul Pâques, CEO Grünenthal and Chairman of the Corporate Executive Board.

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 (sufentanil sublingual tablets) to EMA in July 2014. In November 2014, AcelRx received the approval of the CE certificate for the administration device after successful completion of the conformity assessment by the Notified Body BSI (British Standards Institute).

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. The system is designed to help address certain problems associated with post-operative analgesia, which has been shown to cause harm to patients following surgery because of the side effects of opioids such as morphine, the invasive IV route of delivery of current systems for patient-controlled analgesia (PCA) and the complexity of infusion pumps. 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.

Contact: Friederike Herrfurth, Head Corporate Communications Tel.: +49-241-569-1335, Friederike.herrfurth@grunenthal.com

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