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news.Symbollon Pharmaceuticals has announced the results of a Phase III clinical trial designed to evaluate the effectiveness of IoGen for the treatment of moderate to severe cyclic pain associated with fibrocystic breast disease.
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In the study, patients were dosed once a day for up to six months with either a 6mg IoGen tablet or placebo. There was no statistically significant difference between the treatment groups on the primary endpoint of pain reduction. The findings demonstrated equivalence between the active 6mg IoGen formulation and the placebo in achieving the primary efficacy endpoint. The data also showed no statistically significant difference between the two groups in achieving the secondary efficacy endpoint of fibrosis reduction.
The study randomized 142 patients. Of this group, 61 patients were included in the IoGen intent-to-treat group and 65 patients in the placebo intent-to-treat group. IoGen was clinically successful in achieving the primary efficacy endpoint of pain reduction in 34 of 61 (56%) patients, compared to positive responders in the placebo group of 38 of 65 (58%) patients. IoGen was successful in achieving the secondary endpoint of at least 25% reduction of fibrosis in 38 of 54 (71%) patients, compared to positive responders in the placebo group of 39 of 61 (64%) patients.
Paul Desjourdy, president and CEO of Symbollon, said: “While we will continue to evaluate the data, the results of this study will severely limit our ability to proceed with the clinical development of IoGen.”