Columbia Labs Gets Positive Results in Buccal Phase 3

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Columbia Laboratories


said its buccal tablet raised blood-testosterone levels more effectively than a patch-delivered system in a phase 3 trial.

The company said the results will be presented to the Food and Drug Administration in December when the company seeks a preliminary new drug application for the drug, which treats a condition in which the testes produce inadequate hormone levels.

The trial was conducted on 66 men and compared the tablets to Andropatch, a

SmithKline Beecham

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product that is licensed in the U.K.