FDA Makes Decision on Abuse-Deterrent Formulations of Oxycontin Drug Products
Grünenthal recently announced it is pleased with the US 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 US. 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 this 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 US. Prescription drug abuse is the fastest-growing drug problem in the US, and drug overdose death rates have risen steadily in the US. 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.
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. These investments amounted to about 25% of revenues in 2011. Grünenthal’s research and development strategy concentrates on selected fields of therapy and state-of-the-art technologies. The company is 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. 4,200 employees are working for the Grünenthal Group worldwide. In 2011, Grünenthal achieved revenues of € 947 mn. More information: www.grunenthal.com.
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