By avoiding the effects on the gastrointestinal tract and first-pass metabolism seen with some oral products, transdermal drug therapies can enhance therapeutic efficacy while decreasing side effects. Over the last few decades, numerous companies have introduced to the marketplace novel therapeutic products that utilize transdermal drug delivery technology. That tradition of innovation continues to be alive with DURECT company, which continues refining and improving various attributes of transdermal products with the development of the Transdur™ transdermal dosage form technologies. Developing small, non-irritating and user-friendly products with excellent skin-adhesion are the main objectives for the Transdur™ technology, which are major differentiating factors among patients and physicians. First generation transdermal products fall short of these objectives, in part, because of their use of a liquid drug-reservoir and skin-irritating additives such as alcohols.
Depending on the drug and its physicochemical properties, the Transdur™ technology provides compatible and functional transdermal formulations, resulting in thin solid state transdermal products that can deliver drugs, through intact skin, at a controlled rate up to 1 week. Transdur™ technology encompasses proprietary product components such as pressure sensitive adhesive formulations, skin permeation enhancers and carrier films depending on the application, which enable DURECT's scientists to expand the range of drugs that can be delivered transder-mally (Fig. IV-41). Transdermal products based on Transdur™ technology improve convenience and compliance as well as cost-effectiveness, and provide highly reliable therapy to patients and health care provider.
The transdermal Transdur™-Sufentanil patch is a joint venture of Durect Corporation and Endo Pharmaceuticals Inc. It is intended to provide continuous delivery of sufentanil for up to 7 days from a single application, as compared to the 3 days of relief provided by currently available opioid patches. Sufentanil is an offpatent, highly potent opioid that is currently used in hospitals as an analgesic. The company anticipates that the small size of the sufentanil patch (Fig. IV-41), which is potentially as small as 1/5th the size of currently marketed transdermal fentanyl patches for a therapeutically equivalent dose and a longer duration of delivery, may offer improved convenience and compliance for patients.
In October 2004, a Phase I clinical trial for Transdur™-Sufentanil, consisting of a pharmacokinetic study in normal, healthy volunteers in Europe was initiated. The objectives of the clinical study were to determine the safety and tolerability of Transdur™-Sufentanil as well as to evaluate the pharmacokinetics of sufentanil following administration of Transdur™-Sufentanil. The study evaluated 24 subjects using Transdur™-Sufentanil. No clinically significant adverse events were reported. Some slight to moderate redness at patch site was observed by patients in the trial. Preliminary pharmacokinetics showed a rapid onset of the drug and the targeted plasma level over a 7 day period was achieved. A clinical trial of the Phase II program for Transdur™-Sufentanil was started in February 2005 at two clinical sites, one in the United States and the other in Europe. The clinical trial was an open-label study that was designed to evaluate the transition of chronic pain patients from Duragesic®, the commercial fentanyl patch, to the Transdur™-Sufentanil patch. The clinical study also evaluated the pharmacokinetics and safety of repetitive applications of Transdur™-Sufentanil in patients for a period of up to 4 weeks.
Evaluation of plasma level data indicate that Transdur™-Sufentanil performed as designed by achieving its target delivery profile of providing a rapid onset of drug and a delivery duration of over 7 days. Targeted plasma levels over the consecutive 4 week period (repetitive applications of Transdur™-Sufentanil) were achieved as intended. The product was tolerated well with no apparent safety issues over the 4 week treatment period. As this was an open label study, conclusions on efficacy cannot be drawn; on the average, pain levels remained stable after the transition to Transdur™-Sufentanil.
Endo Pharmaceuticals will have the exclusive rights to develop, market and commercialize Transdur™-Sufentanil in the US and Canada and full marketing rights in the rest of the world.
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