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FENTANYL TDS

AMARIN has developed a Transdermal Delivery System (TDS) for Fentanyl, a narcotic analgesic agent, formulated as a drug-in-adhesive monolithic-type device.

AMARIN´s Fentanyl TDS is a transparent thin device designed to release fentanyl continuously upon application to skin. This device has demonstrated an excellent chemical and physical stability and comprises three structures:
  • A transparent and flexible film (backing).
  • A two-layer adhesive formulation containing fentanyl and excipients (including permeation enhancer).
  • A polyester release liner that is attached to the adhesive surface and must be removed before its application.
AMARIN´s Fentanyl TDS is indicated for the management of chronic and severe pain in patients who require continuous opioid analgesia.

Eight preclinical studies and two pharmacokinetic pilot studies in humans have been carried out during the formula optimization of Amarin’s Fentanyl TDS. Finally, two regulatory bioequivalence studies (n=34-35) were conducted in Germany with the final formulation. Amarin’s Fentanyl TDS proved to be bioequivalent to Durogesic® SMAT both under single-dose and multiple-dose regimens.

Dose linearity has also been demonstrated for Amarin's Fentanyl TDS.

A patent application has been filed at the Argentinean and UK Patent Offices in 2002, and an International Patent Application was filed in 2003. The European Patent was granted in 2007 and was also applied in USA, Mexico and India.

The product is being commercialized by Sandoz in Argentina (Talnur®) since 2006. Four strengths of Amarin’s Fentanyl TDS are currently being sold by different companies in Europe and Asia. Amarin’s Fentanyl TDS is under registration in other countries of South America, Europe, Asia and South Africa.
 


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