Aachen, 17th April 2013 – Grünenthal is pleased with the U.S. Food and Drug Administration’s (FDA) recent decisions regarding abuse deterrent formulations (ADF) and prescription opioids. In its response to a citizen petition by Purdue, generic equivalents to the reformulated abuse deterrent formulation of OxyContin will be required to have similar abuse deterrent properties and undergo specific testing requirements to demonstrate these properties.
Grünenthal is pleased with the U.S. Food and Drug Administration’s (FDA) recent decisions regarding abuse deterrent formulations (ADF) and prescription opioids. In its response to a citizen petition by Purdue, generic equivalents to the reformulated abuse deterrent formulation of OxyContin will be required to have similar abuse deterrent properties and undergo specific testing requirements to demonstrate these properties. Additionally, the FDA has approved the inclusion of abuse deterrent wording in the OxyContin label. These moves by the FDA are steps in the right direction, reinforcing the value of abuse deterrent formulations in addressing prescription opioid misuse and abuse health crisis in the Unites States. The FDA has stated that such decisions will be made on a case by case basis. In its response to a similar citizen petition from Endo regarding Opana ER, the FDA indicated that their decision on this product will be communicated in May.
Grünenthal has dedicated itself to the needs of pain patients. As a manufacturer specializing in innovative treatments and better solutions for the management of pain, Grünenthal is committed to developing innovative, effective products and to help ensure their appropriate use. Grünenthal’s INTAC® technology helps safeguard the intended drug release of oral opioids while providing patients the same effective pain relief of conventional formulations. Tablets produced using INTAC® technology are designed to resist crushing, impeding the key step in most forms of non-oral opioid abuse. Prescription opioids are at the center of a major public health crisis of misuse and abuse in the United States.
Prescription drug abuse is the fastest-growing drug problem in the U.S., and drug overdose death rates have risen steadily in the U.S. Technological approaches that intend to prohibit or reduce the ability to tamper with specific time-release drugs through crushing are an effective means to address the issue.
Technology Tablets produced using INTAC® technology are designed to resist crushing even by heavy hammer blows, foiling the key step in most forms of opioid abuse. In addition to their high breaking strength, tablets produced by the INTAC® process form a gel in aqueous solutions that cannot be readily injected, and they resist extraction of active drug by a wide range of solvents. The mechanical stability is created by the combination of specific excipients together with a unique manufacturing process. INTAC® is the leading tamper resistance technology now in use, with two FDA-approved products already available in the United States. INTAC® manufacturing is established on a commercial scale in the U.S. and Europe. The technology is available for licensing to interested companies for various opportunities. Companies licensing INTAC® technology for their products are following a proven approach with a track record of regulatory approval.
For more information about INTAC® please visit: http://www.intac.grunenthal.com.
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 and thus to be a leader in therapy innovation. Grünenthal is one of the last remaining five research-oriented pharmaceutical companies with headquarters in Germany which sustainably invests in research and development. The research and development costs amounted to a preliminary of about 26 percent of revenues in 2012. 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 26 countries worldwide. Grünenthal products are sold in more than 155 countries and today approx. 4,400 employees are working for the Grünenthal Group worldwide. In 2012, Grünenthal achieved preliminary revenues of € 973 mn.
More information: www.grunenthal.com.