Grunenthal To Present Data for its Innovative Formulation Technology INTAC® at PAINWeek 2012

BEDMINSTER, N.J. and AACHEN, Germany, Sept. 5, 2012 /PRNewswire/ -- Grunenthal, a global family-owned pharmaceutical company specializing in pain management, today announced the company's planned activities at this year's PAINWeek^®, the National Conference on Pain for Frontline Practitioners, taking place in Las Vegas, NV from September 5 – 8, 2012.

The company will present data at a poster session from a study examining bioequivalence of the INTAC^® technology with conventional extended-release (ER) formulations containing opioid substances. The poster will be presented on Thursday, September 6 from 6:30 – 8:30 pm at the Exhibit Hall, Chelsea Ballroom, Level 4 (poster number 129).

While tablets using the INTAC^® technology are difficult to tamper with, the study showed that tablets using the INTAC^® technology had comparable in vivo performance as their standard ER formulations. The study specifically showed the following:

• Bioequivalence demonstrated for the tamper-resistant formulation (TRF) to the reference marketed ER product over a 10-fold range of dose strengths.
• Similar times to reach maximum concentrations and prolonged release characteristics observed for both INTAC^® and standard formulations.
• Adverse event profile of INTAC^® tablets in line with marketed reference.

INTAC^® is a formulation platform that provides crush-resistance to tablets as a means of tamper deterrence while keeping the intended time-release characteristics of the product. 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.

Prescription opioids are at the center of a major public health crisis of misuse and abuse in the United States.[1] 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 abuse specific time-release drugs by tampering with the formulation through crushing are therefore an effective means to address the issue.

"We are excited to be presenting at this year's PAINWeek conference. The problem of opioid abuse in the United States matters to everyone. The development of dependable tamper-resistant drug formulations is a key priority in addressing this public health crisis," said Alexander Kraus, Ph.D., Head of Global TRF Business at Grunenthal. "INTAC^® technology helps safeguard the intended drug release of oral opioids while providing patients the same effective pain relief of conventional formulations."

Grunenthal will also have a booth dedicated to the INTAC^® technology. Attendees will be able to test the difference in crush resistance of INTAC^® tablets versus conventional prolonged release tablets themselves by actually trying to crush the tablets with a hammer. The company will host several Meet-the-Expert presentations at the booth that will include opportunities to speak with Eric Galia, Ph.D., Project Director International Technical Alliance Management at Grunenthal, and Birger Wenge, Ph.D., Clinical Pharmacologist at Grunenthal.

About INTAC^® 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 solutions that cannot be readily injected or snorted, 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 at 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.

About Grunenthal
The Grunenthal 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.

Grunenthal 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 percent of revenues in 2011. Grunenthal'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 Grunenthal Group has affiliates in 26 countries worldwide. Grunenthal products are sold in more than 155 countries and today approximately 4,200 employees are working for the Grunenthal Group worldwide. In 2011, Grunenthal achieved revenues of € 947 mn. More information please visit www.grunenthal.com.

[1] Epidemic: Response to America's Prescription Drug Abuse Crisis. Executive Office of the President of the United States, 2011.

SOURCE Grunenthal Group