A multicentric, randomized, open-label study will evaluate the efficacy and safety of Sufentanil TDS.
A phase II clinical development program for a sufentanil transdermal patch has begun, according to the patch manufacturer Labtec GmbH, Langenfeld.
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.
The possible advantages of sufentanil lie in its seven-fold higher potency together and its better side-effects profile and higher safety margin. Due to its very small size and its textile backing, the patch offers a high level of 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” said Labtec’s Managing Director, Dr. Ingo Lehrke, in a press release.
On June 4, 2010 Labtec 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 said, in a press release: “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.
Hameln rds was spun off from hameln pharmaceuticals gmbh in 2005 under the name hameln pharma r&d gmbh. The company offers a range of services from drug development right through to drug sales and distribution.
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