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news.ProStrakan Group has announced positive results from the pivotal US clinical program on Fortigel for testosterone replacement therapy in hypogonadal men. Based on these results, ProStrakan expects to re-file Fortigel with the FDA in the third quarter of 2008.
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The ‘Fortify’ study met all primary and secondary endpoints, demonstrating that the product was able to maintain adequate testosterone levels within all of the pharmacokinetic parameters agreed with the FDA under special protocol assessment. The study involved 149 men aged 29-77 and was conducted between August 2007 and March 2008.
Fortigel is a patented 2% testosterone transdermal gel, which utilizes a proprietary metered dose delivery system that permits dose adjustment to individual patient requirements. Fortigel is branded as Tostran, Itnogen or Tostrex in the EU.
ProStrakan owns the global intellectual property rights to Fortigel and the product forms an important part of the company’s commercial strategy in Europe and the US. It contains a higher concentration of testosterone than other gel formulations, allowing patients to apply a smaller volume.
Wilson Totten, CEO of ProStrakan, said: “The US market for testosterone products is the most developed in the world and Fortigel has the potential to become a major product for ProStrakan in the US, with NDA filing later this year and, subject to approval, launch in the US mid 2009.”