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Home Industry News ProStrakan announces enrolment in Tostran and Rectogesic trials

ProStrakan announces enrolment in Tostran and Rectogesic trials

20th August 2007

ProStrakan has announced that it has begun enrolment in two pivotal clinical studies for Tostran and Rectogesic – known as Fortigel and Cellegesic respectively in the US.

Tostran is a two per cent testosterone gel used as a replacement therapy for male hypogonadism following the confirmation of clinical symptoms of testosterone deficiency by a laboratory, while Rectogesic is a rectal ointment used for pain relief in patients with chronic anal fissures.

Both drugs have already received approval in the European Union, while these upcoming clinical trials are part of the firm’s efforts to attain authorisation from the US Food and Drug Administration.

Dr Wilson Totten, chief executive of ProStrakan, said: “Commencing these pivotal trials so soon after acquiring the US rights is a major achievement.”

He added that the firm is confident that by 2009 it will have a considerable US drug portfolio that will make a key contribution to the development and performance of ProStrakan, with this announcement following soon after the initiation of the new drug application approval process for Sancuso.

Last month, ProStrakan announced the filing of a marketing authorisation application for Sancuso in the European Union as a therapy for nausea and vomiting resulting from treatment with chemotherapy.

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