The Swiss R&D company APR Applied Pharma Research s.a. ("APR") and the Italian pharmaceutical company Fida Farmaceutici S.p.A. ("Fidia") partnered together to co-develop and co-license out the Diclofenac sodium Patch to pharmaceutical companies interested to market this product under their own brand name. APR owns a 50% stake in the project and Fida  owns the remaining 50%.

Diclofeanc sodium Patch is a matrix patch consisting of 3 distinct layers: the first layer is a transpirant woven  polyester material longwise and crosswise elastic assuring perfect adhesion also when applied on joints like knee or elbow; the second layer is the adhesive layer containing and delivering the active ingredient through the skin and the third layer is the protective release liner to be removed prior application.

The Diclofenac sodium Patch has the following advantages compared with the existing topical medicated plasters:

a) Very good adhesive properties

b) Longer and more constant drug flux through the skin

c) No clothes contamination during treatment

d) Fixed dressing especially for joints

The product has been developed according to the "Note for Guidance on the Clinical requirements for locally applied, locally acting products containing known ingredients" (CPMP/EWP/293/95 dated June 96).

Preclinical studies have been all successfully completed to assess safety and tolerability of the product. 

PK studies comparing our Diclofenac Matrix Patch vs. marketed diclofenac plasters are successfully completed.

The Product is registered and marketed in Italy since early 2005.

APR and Fidia anticipates completion of 2 Pivotal Phase III Efficacy and Tolerability studies on patients for 4Q2008 in order to register the product in other countries other than Italy.

Patent on product and process pending and under PCT procedure.

The product is available for licensing in all the countries worldwide other than Italy where the product is marketed by Novartis Consumer Health with the brand of Voltadol under license from APR and Fidia.