Scotland’s ProStrakan Group has begun recruiting the first patients for pivotal trials that it hopes will lead to US approval for two of its lead products, the testosterone replacement therapy Fortigel and its anal fissures treatment Cellegesic.

First up is Fortigel (2% testosterone gel), which is sold in Europe as Tostran and is used as replacement therapy for male hypogonadism when testosterone deficiency has been confirmed. The ‘Fortify’ Phase III trial is looking to enrol 140 hypogonadal male patients across 30 sites in the USA and the company noted that the primary endpoint is based on the percentage of patients achieving normal blood testosterone levels.

APT is the name of the Phase III study for Cellegesic (glyceryl trinitate), a rectal ointment marketed in Europe as Rectogesic. ProStrakan hopes to enrol 246 patients suffering from chronic anal fissures across 40 locations in and out of the USA and the primary endpoint of this placebo-controlled study is based on relief from anal fissure pain. If approved in the USA, Cellegesic will be the first pharmacologic treatment indicated for pain associated with chronic anal fissures.

It is anticipated that top-line results from both studies will be available in the second half of 2008, and if the Food and Drug Administration is sufficiently impressed, the US launch of both products is planned for 2009. Both of the medicines have been performing well in Europe this year and demand for Tostran in the UK and Germany has been strong since they hit the market in both countries in June. The French launch is well under way, and Tostran will be available in Spain and Italy by the end of the year, when Rectogesic should also be launched on all major European markets.

ProStrakan acquired the outright worldwide rights to Rectogesic and Tostran from US-based partner Cellegy Pharmaceuticals at the end of last year and chief executive Wilson Totten said that “commencing these pivotal trials so soon after acquiring the US rights is a major achievement”.

He added that with the New Drug Application process for Sancuso (granisetron), a transdermal patch for the prevention of chemotherapy-induced nausea and vomiting, already under way, “I am confident that, by 2009, we will have a substantial US business in place”.