WASHINGTON (Reuters Health) - Columbia Laboratories said on Friday that it has submitted a US marketing application for its buccal bioadhesive testosterone.

The Livingston, New Jersey-based firm is seeking to market the testosterone replacement therapy for the treatment of male hypogonadism. The company anticipates launching the product as early as next year.

The product was designed to deliver 30 mg of testosterone using the firm's patented bioadhesive delivery system and hydrating buccal technologies.

Columbia Labs said the marketing application contained data from two controlled clinical trials and two ongoing long-term safety trials. One US phase III trial involving 98 hypogonadal men showed use of the product resulted in a mean testosterone blood level of 5.3 ng/ml in 85% of the participants over a period of 24 hours, according to the company, which added that the normal range is 3.0-10.5 ng/ml.

Side effects were minimal, with local irritation being the most often reported event, the company said.

Columbia said another trial in two European countries helped demonstrate that the mean testosterone levels for patients using its product were higher than those on patients using GlaxoSmithKline's marketed therapy, the Andropatch. Mean levels achieved with Columbia Labs' product were 5.4 ng/ml, compared with 3.7 ng/ml for the Andropatch group, the drugmaker said.

A corporate spokesman told Reuters Health additional details would be revealed during a conference call scheduled for Wednesday.

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