Vitaros®, the topical cream produced by Apricus Biosciences,
can now be marketed in Europe. It has recently been approved through the
European Decentralised Procedure. The cream is designated to treat patients
with Erectile Dysfunction.
The cream’s active ingredient is alprostadil, which is a
vasodilator. The product also contains a permeation
enhancer (NexACT®). This medication is unique because alprostadil has
only been able to be administered to patients via injection or pellet.
Therefore Vitaros® cream becomes a much more desirable option and targets those
men with erectile dysfunction that were wary of the earlier applications of the
active ingredient.
The Netherlands applied, as a reference member state, on
behalf of Belgium, France, Germany, Italy, Ireland, Luxembourg, Spain, Sweden,
and the UK. Apricus Biosciences will partner up with other European businesses,
such as Takeda, Sandoz and Bracco, in order to market the product throughout
Europe.
Apricus Biosciences is also looking to treat Female Sexual
Arousal Disorder (FSAD) with Femprox®. This cream also has alprostadil as the
main active ingredient, along with the DDAIP.HCL proprietary permeation enhancer.
Experimental studies have been completed in the US and in China. We await
further information on this product.