Labtec initiates Sufentanil TDS phase II clinical development program for chronic cancer pain

Labtec GmbH, Langenfeld, Germany announces the start of the phase II clinical development program for its sufentanil transdermal patch. The multicentric, randomized, open label study will evaluate efficacy and safety of Sufentanil TDS against standard treatment in patients with chronic cancer pain.

Sufentanil TDS is a matrix-type transdermal patch with the active ingredient sufentanil, a highly potent and well-known opioid analgesic that is used as an injection or infusion for anesthesia and analgesia since decades. Compared to fentanyl, the advantages of sufentanil lie in its seven fold higher potency together with a superior side effect profile and higher safety margin. Due to its very small size of only 3 cm² and its textile backing the patch offers the high wearing comfort for the patient.

"After the huge success of our Fentanyl patch, which is marketed by our licensee ratiopharm and several other leading generic companies in Europe and Canada, we are expecting 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 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.

On June 4^th, 2010 Labtec has entered into a strategic development partnership with hameln rds GmbH, Hameln, Germany. Under the agreement, hameln rds will perform all necessary development steps jointly with Labtec to bring the product through phase II.

Dr. Peter Klaffenbach, Managing Director of Labtec: "We are glad that we found in hameln rds a highly professional and competent partner for the development who will conduct all necessary pre-clinical studies as well as the clinical studies phase II. All studies will be organised and realised at hameln rds´s research and development site in Modra, Slovakia, where hameln rds holds large laboratory capacities with innovative equipment as well as its own in-house clinic."

Labtec is the manufacturer of the pilot batches for the pre-clinical and clinical studies. Labtec will also conduct the scale up process at its manufacturing site in Hamburg. The first toxicological studies are already in progress at the research and development site of hameln rds in Modra.