biotech
Novel Testosterone Cream On Track for Q4 2007 Launch
Filed in archive Drugs, Vaccines and Therapeutics by ruth on February 2, 2006
Male Hypogonadism: Basic, Clinical, and Therapeutic Principles (Contemporary Endocrinology)

Ardana, a Scotland-based firm focusing on reproductive health, announced that, during its pre-Investigational New Drug (IND) meeting with the US FDA, an agreement has been reached on the next steps in the developments of its novel cream for testosterone replacement therapy for the treatment of male hypogonadism.

Dr Maureen Lindsay, Ardana's CEO, said: "We are very encouraged by the feedback from the FDA and by the progress of development of this novel testosterone cream, which complements our current and planned portfolio. We believe that the delivery technology has broad application and we are assessing additional compounds which could be developed using this platform."


Enrolment to a Phase II dose finding study in the target patient population has now been completed, while a Phase II dose-titration study in support of the registration of Ardana's testosterone cream is also on track to commence this year. Ardana approximates the treatment available for launch towards the last quarter of 2007.

Ardana

Permalink: Novel Testosterone Cream On Track for Q4 2007 Launch
Tags: testosterone  hypogonadism  biotech  cream  novel  novel+testosterone  testosterone+cream  2007+launch 
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