Apricus Biosciences of the USA says that Vitaros, its topically-applied cream formulation of alprostadil, has been approved for erectile dysfunction in 10 European countries.
The green light comes courtesy of the European decentralised procedure and the Netherlands acted as reference member state on behalf of France, Germany, Italy, the UK, Ireland, Spain, Sweden, Belgium and Luxembourg. The active ingredient in Vitaros, alprostadil, is already found in other ED drugs but Takeda, which will market the treatment in the UK, noted that patients have been "deterred by the current methods of administration of other alprostadil-containing medicines", ie pellet or injection.
Richard Pascoe, Apricus Bio chief executive, claimed that Vitaros has "a unique product profile that meets the needs of a large number of patients suffering from ED and who are intolerant to or do not respond to current treatment options". He added that with its "rapid onset of action and "unique topical delivery", the drug could capture a significant share of the $1 billion phosphodiesterase type 5 (PDE-5) inhibitor market in Europe, dominated by Pfizer's Viagra (sildenafil), Eli Lilly's Cialis (tadalafil) and Bayer's Levitra (vardenafil).
As well as Takeda, Apricus Bio has signed up other partners for Europe, such as Sandoz for Germany and Bracco in Italy. Vitaros has also received marketing authorisation in Canada, where it has been licensed to Abbott Laboratories, while US commercial rights are held by Warner Chilcott.
Mr Pascoe added that partnering interest in Vitaros remains strong "and we are actively seeking to secure additional partnerships in the remaining European and global markets". The firm has just completed a $17.1 million financing and the divestiture of "multiple non-core assets".
Female sexual arousal drug
As well as Vitaros, Apricus Bio is also developing Femprox, also an alprostadil-based cream, for female sexual arousal disorder. Seven clinical studies have been successfully completed to date, including one, 98-subject Phase II study in the USA and a nearly 400-subject Phase III trial in China.
There are no approved products for FSAD and Apricus Bio is now hoping to meet with the US Food and Drug Administration shortly to get guidance regarding its next move, regulatory-wise.