FDA approval of reformulated scheduled analgesic product using Grünenthal's INTACTM technology
Aachen, Germany, December, 12th 2011. Today the U.S. Food and Drug Administration (FDA) approved a reformulation of Endo Pharmaceuticals' Opana® ER, an extended release opioid analgesic designed to be crush-resistant employing Grünenthal's proprietary INTACTM Technology.
INTACTM is an innovative formulation technology with the aim to protect intended drug action: specific polymer compositions and a unique manufacturing process yield tablet formulations with crush-resistant properties while preserving desired release characteristics.
INTACTM technology offers tailor made release properties to achieve bioequivalence to a variety of conventional easily crushable formulations facilitating easy switch to the reformulated product.
"We are very proud that the FDA has approved another product which utilizes our proprietary INTACTM technology", said Dr. Klaus-Dieter Langner, COO of Grünenthal Innovation, the research division of Grünenthal GmbH, "and would like to congratulate our partner Endo Pharmaceuticals on this achievement."
The Grünenthal Group is an independent, family-owned international research based pharmaceutical company headquartered in Aachen, Germany. Building on its unique position in pain, its objective is to become the most patient-centric company and to be a leader in therapy innovation. Altogether, the Grünenthal Group has affiliates in 36 countries worldwide. Grünenthal products are sold in more than 100 countries and approx. 4,900 employees are working for the Grünenthal Group globally. In 2010, Grünenthal reached revenues of about 910 Mio €.
More information: www.grunenthal.com.
Vice President Corporate Communications
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