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news.Depomed, a specialty pharmaceutical company, has completed enrollment of Breeze 2, the second of two pivotal Phase III clinical trials of Serada for the treatment of menopausal hot flashes.
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Depomed’s Phase III registration program for Serada in menopausal hot flashes includes two randomized, double-blind, placebo-controlled studies of approximately 540 patients per study.
The treatment duration of the Breeze 1 study is six months, with primary efficacy endpoints assessed after four and 12 weeks of stable treatment. Persistence of efficacy will be assessed at six months as one of the secondary endpoints. The treatment duration in the second study, Breeze 2, is three months, also with assessment of efficacy at four and 12 weeks. Preliminary top-line data is expected to become available in the fourth quarter 2009 for both studies.
Carl Pelzel, president and CEO of Depomed, said: “We are encouraged by the level of interest in a non-hormonal alternative treatment for menopausal hot flashes that we noticed during the recruitment of patients.”