FENTANYL TDS
Amarin Technologies has developed a Fentanyl TDS, a narcotic analgesic agent, formulated as a drug-in-adhesive type device.
This device produces a sustained release of fentanyl during 72 h.
Fentanyl TDS is indicated for the management of chronic and severe pain in patients who require continuous opioid analgesia.Two regulatory bioequivalence studies were conducted in Germany , in which Fentanyl TDS proved to be bioequivalent to Durogesic® matrix both under single-dose and multiple-dose regimens.
The patch has been approved and is being currently marketed in european countries as well as in Taiwan and Argentina.
Nowadays, Amarin is engaged in the development of a new version of its Fentanyl TDS, for the US market.
A Phase I study is scheduled for Q3, 2010.
NSAID THERAPY
DICLOFENAC GEL
Amarin Technologies has under development a gel of diclofenac sodium 1%, which has a formula similar to that of Voltaren Gel marketed in USA.
The release profile of Amarin’s Diclofenac 1% Gel is comparable and equivalent to that of Voltaren Gel, according to “in vitro” tests carried out by means of Franz diffusion cells.
In a multiple–dose, wearing test carried out in 6 healthy subjects, the performance of a gel was similar to Voltaren® Gel, and plasma diclofenac levels were also closely similar between both products.
A phase I study is scheduled for Q4 2010.
DICLOFENAC TDS
Amarin Technologies has also under development a once-daily topical patch containing diclofenac sodium 1%.
This product is intended for the treatment of acute pain due to minor strains, sprains and contusions.
A comparative bioavailability study is scheduled to be conducted in Q4 2010.
PSYCHIATRY/NEUROLOGY
ANTI-DEPRESSION TDS
Amarin Technologies has developed a patch for the treatment of major depressive disorders.
This product is nowadays in a pre-registration phase in USA.
ANTI-ALZHEIMER TDS
Amarin Technologies has under development a transdermal system for the treatment of mild to moderate dementia of the Alzheimer’s type, and for the management of mild to moderate dementia associated with Parkinson’s disease.
A phase I bioavailability study is scheduled to be conducted in Q3, 2010.
