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INTAC™ Technology Combats Misuse of Extended Release Drugs
Date:5/15/2012

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[1]. 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.

About INTAC™

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
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