Clinical Trials Resource Center

Fibrocystic Breast Disease

April 14, 2008

Symbollon Pharmaceuticals released negative results from a phase III trial of IoGen for the treatment of moderate to severe cyclic pain associated with fibrocystic breast disease. This randomized study enrolled one hundred and forty two subjects who received a 6 mg IoGen tablet or placebo once a day for up to six months. Data showed there was no statistically significant difference between the IoGen and placebo treatment groups on both the primary and secondary endpoints. The primary efficacy endpoint was pain reduction; this was reached in 56% of subjects in the IoGen arm compared to 58% of subjects in the placebo arm. The secondary endpoint was at least a 25% reduction of fibrosis. This endpoint was reached in 71% of the subjects in the IoGen arm compared to 64% of subjects in the placebo arm. The incidence of adverse events was similar between the treatment arms. Symbollon plans to fully analyze the data in order to determine the future of IoGen.

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