TopoTarget says failed Aguvane study was worthwhile

29 March 2009

Although Danish firm TopoTarget's Avugane gel (valproic acid) failed to reach significance in a Phase II trial comparing three doses of the acne  medication, the company says the results warrant further studies.

The double-blind, randomized, parallel-group, placebo-controlled,  dose-finding study compared the efficacy and safety of topically-applied  Avugane of different concentrations in subjects with mild-to-moderate  acne vulgaris. 70 patients with facial acne were randomly allocated to a  12-week topical treatment with Avugane 0.5%, 3%, 6% or a placebo.

Early in the trial, the 6% gel showed stability problems and this arm of  the study was discontinued. However, the firm says this trend in the  efficacy assessment report supports a trial of a new and more stable  formulation of 6% Avugane. TopoTarget intends to out-license the drug to  a partner with expertise in the dermatology field.

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