ProStrakan announces positive testosterone results

ProStrakan has announced positive results from its pivotal clinical profile for Fortigel (testosterone two per cent gel), known as Tostran in the EU, as a testosterone replacement therapy in hypogonadal men.

In the Fortify study, the compound met all its primary and secondary endpoints, maintaining adequate testosterone levels in all pharmacokinetic parameters agreed with US regulators under special protocol assessment.

As a consequence of these positive results, the firm aims to re-file the drug with the US Food and Drug Administration in the third quarter of this year.

Dr Wilson Totten, chief executive of ProStrakan, said that the compound would be the second product from the firm available in the US, following it planned launch of Sancuso later this year.

“We are now well on track with our strategy to grow a significant US speciality pharmaceutical business, in addition to our European infrastructure, through which we can market our range of new medicines designed for easier patient use.”

In April 2008, ProStrakan announced that it had been granted marketing authorisations in the UK and other European countries for Xomolix (droperidol) as a treatment for post-operative nausea and vomiting.

Sales of the compound reached 4.2 million pounds in 2007.