LANGENFELD, Germany, April 25, 2007-Labtec GmbH (Langenfeld, Germany), a specialty pharmaceutics company announces positive results from a multiple dose clinical study for their proprietary Sufentanil transdermal patch.
“Today, we are pleased to announce the successful completion of the second clinical trial for our Sufentanil TDS®. Our goal for this program was to complete this study in the first half of 2007,” says Dr. Armin Breitenbach, Labtec's Director of Pharmaceutical Development. “Based on the positive results of the first Phase I trial for our Sufentanil patch that showed good safety, tolerability and extended drug release, we initiated this trial end of last year. The objectives to demonstrate effective plasma levels and safety of repetitive applications of our Sufentanil patch were fully met. We believe that this product, once approved, will provide a significant improvement over currently available pain management therapies on the market today.”
Labtec's transdermal Sufentanil product is intended to provide extended chronic pain relief for several days. The patch is not only very small but at the same time has an unusually low drug content. The proprietary formulation releases the drug with an unparalleled efficiency. Additional patient comfort is achieved by the use of a special non-woven backing. Unlike most backing films used in transdermal systems, this material is non-occlusive, allows the skin to breathe and maintains its integrity throughout the application period.
“After the huge success story of our Fentanyl patch, which is marketed by our licensee ratiopharm and several other leading generic companies in Europe, we are looking forward to see our Sufentanil TDS® move forward. In our opinion this transdermal patch is the logical next generation product for severe chronic pain. Sufentanil is one of the most potent drugs in its class, seven times more potent than Fentanyl and at the same time offers various advantages in terms of safety and efficacy for chronic pain treatment with a transdermal system” says Labtec’s Managing Director, Dr. Ingo Lehrke.
Beginning with phase II clinical development Labtec is now willing to enter into a global development and licensing agreement with a strong and committed partner.
Labtec GmbH is a leading drug delivery company specialised on development of matrix-type transdermal and topical patches as well as fast dissolving oral films (Rapidfilms).
Dr. Ingo Lehrke; Managing Director; Business Development & Licensing
Labtec GmbH | www.labtec-pharma.com | Raiffeisenstrasse 3a | D-40764 Langenfeld | Germany | T: +49 2173 9735-0