Grünenthal Gruppe

An innovative pain treatment will be tested in one of the largest clinical trials in cancer pain

Aachen (ots) - More than 500 patients, who suffer from severe chronic pain related to cancer in can participate in one of the largest trials in cancer pain in 145 hospitals spread over 21 countries world-wide.

Many cancer patients suffer from severe chronic pain related to their cancer. Unfortunately many of these patients are not satisfied with their current treatment options for the management of their pain due to the limitations of these treatments.(1) The German pharmaceutical company Grünenthal is investigating the efficacy and safety of the new analgesic cebranopadol for the treatment of severe chronic pain and peripheral neuropathic pain. Patients suffering from cancer-related severe pain are encouraged to check if they qualify to participate in a large cancer pain phase III trial, the so-called CORAL trial. The CORAL trial aims to show that the investigational drug cebranopadol can provide equally strong analgesia as a standard strong opioid in cancer patients while causing considerably less side effects. As the first trial of cebranopadol's phase III clinical program, referred to as the OCEANIC PROGRAM®, Grünenthal will start the CORAL trial in 145 hospitals spread over 21 countries, including the United Kingdom. More than 500 patients are planned to complete this trial by 2016. More information about the CORAL trial and participating hospitals is available at www.oceanic-program.com

In the CORAL trial, patients suffering from severe chronic pain related to cancer are treated with cebranopadol or with morphine to compare their efficacy and safety. In many countries morphine is considered as the standard therapy for the treatment of cancer pain, but has numerous limitations for patients on e.g. side-effects. Therefore, the CORAL trial is designed to evaluate which additional benefits cebranopadol can provide to patients suffering from severe chronic pain related to cancer, compared to morphine.

"Cebranopadol is the latest development from our R&D pipeline", Dr. Klaus-Dieter Langner, Chief Scientific Officer and member of the Corporate Executive Board at Grünenthal explained. "We at Grünenthal strive for a continuous improvement of the quality of life for our patients. For patients suffering from severe chronic pain related to cancer, we hope the CORAL trial will demonstrate that it is possible to improve their situation. Therefore we call on patients with severe cancer-related pain to participate in the CORAL trial to help us to further understand the potential of this new medicine and bring this to the patient as soon as possible."

About cebranopadol

Cebranopadol was discovered by scientists at Grünenthal, a pharmaceutical company based in Germany. It is now being developed internationally for the treatment of different pain conditions by Grünenthal and its development partner Forest Laboratories, Inc., a pharmaceutical company based in the United States. Cebranopadol is currently in clinical development and is not yet approved or registered in any country, which means that it is not publicly available, not even in pharmacies.

Cebranopadol is a novel analgesic working as a NOP and opioid receptor agonist. Analgesics currently available such as oxycodone, morphine, and fentanyl act on the µ-opioid receptor, but not on the NOP receptor. Based on preclinical studies, cebranopadol has strong and broad analgesic activity in a variety of animal models of acute, inflammatory, visceral, neuropathic, and cancer pain and induces fewer side-effects than pure mu-opioids. The unique mode of action of cebranopadol may be particularly well suited for the management of moderate to severe chronic pain related to cancer, including neuropathic pain. More information at www.oceanic-program.com

About Grünenthal

The Grünenthal Group is an independent, family-owned, international research-based pharmaceutical company headquartered in Aachen, Germany. Building on its unique position in pain treatment, its objective is to become the most patient-centric company in the field of pain and thus to be a leader in therapy innovation. Grünenthal is one of the last five remaining research-oriented pharmaceutical companies with headquarters in Germany which sustainably invests in research and development. Research and development costs amounted to about 27 percent of revenues in 2013. Grünenthal's research and development strategy concentrates on selected fields of therapy and state-of-the-art technologies. We are intensely focused on discovering new ways to treat pain better and more effectively, with fewer side-effects than current therapies. Altogether, the Grünenthal Group has affiliates in 25 countries worldwide. Grünenthal products are sold in more than 155 countries and approx. 5,500 employees are working for the Grünenthal Group worldwide. In 2013, Grünenthal achieved revenues of E901 mn.

References:

1. Breivik H, Collett B. Survey of chronic pain in Europe: Prevalence, impact on daily life and treatment. European Journal of Pain 2006; 287-333

Contact:

Frank Schönrock, Vice President Public Engagement
Tel.: +49 241 569-1568, Fax: +49 241 569-3539,
frank.schoenrock@grunenthal.com

Grünenthal GmbH, 52099 Aachen, Germany, www.grunenthal.com



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