Clinical Data on Grunenthal's Tamper Resistant Formulation Technology to be Presented at APS
BEDMINSTER, N.J., May 15, 2012 /PRNewswire/ -- During this year's Annual Scientific Meeting of the American Pain Society (May 16-19, 2012 Honolulu, HI) Grunenthal will present results from clinical studies utilizing a product based on its INTAC formulation technology. INTAC is designed to be crush-resistant and to protect intended action of extended release drugs. Applying INTAC to prescription opioid drugs is considered an efficient means to combat unintended and intended drug misuse and abuse through tampering with the formulation.
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 US and drug overdose death rates have risen steadily in the US. Technological approaches that intend to prohibit or reduce the ability to abuse specific time-release drugs by tampering with the formulation through crushing are therefore an effective means to address the issue.
Dr. Hans-Jurgen Stahlberg, Director and International Clinical Lead at Grunenthal will present data from a clinical development program aimed at demonstrating bioequivalence between a non-tamper resistant originator product and the product utilizing INTAC formulation technology (Bridging from Conventional Marketed Extended Release Formulations to New Tamper Resistant Alternatives, poster # 391). The structure and regulatory frame for the study program as well as the results and outcome for physicians and patients will be discussed.
INTAC, Grunenthal's tamper resistant formulation technology, is designed to deter various relevant routes of abuse / inadvertent misuse from tablet tampering by imposing a specific mechanical stability to the tablet. This mechanical stability is created by the combination of specific excipients together with a unique manufacturing process. Grunenthal's proprietary INTAC approach is established at commercial manufacturing scale and is featured in FDA-approved products which are marketed by US partners. Grunenthal considers its patent protected INTAC to be the leading technology for abuse-deterrent and tamper-resistant opioid products. The INTAC technology is available for licensing to interested companies for various product opportunities.
The Grunenthal 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 to be a leader in therapy innovation. Grunenthal is one of the last five research-oriented pharmaceutical corporations with headquarters based in Germany which sustainably invests in research and development. These investments amounted to about 25 % of revenues in 2011. Grunenthal's research and development strategy concentrates on select fields of therapy and state-of-the-art technologies. We focus on the intensive search for new ways to treat pain better, more effectively and with fewer side-effects than before. Altogether, the Grunenthal Group has affiliates in 26 countries worldwide. Grunenthal products are sold in more than 155 countries and approx. 4200 employees are working for the Grunenthal Group worldwide. In 2011, Grunenthal reached estimated revenues of 947 Mio euros. More information: www.grunenthal.com.
 Epidemic: Responding to America's Prescription Drug Abuse Crisis. Executive Office of the President of the United States, 2011