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news.Depomed, a specialty pharmaceutical company, has started the enrollment and dosing of the first patient in Breeze 2, the second of two pivotal Phase III clinical trials in the company's registration program for DM-5689 for the treatment of menopausal hot flashes.
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Breeze 1, the first Phase III clinical trial, was initiated in September 2008.
Breeze 2 differs from Breeze 1 in its treatment duration, which will be three months for Breeze 2, with assessment of efficacy at four and 12 weeks only.
Breeze 1’s treatment duration will be six months, with primary efficacy endpoints assessed at four and 12 weeks, and persistence of efficacy assessed at six months as one of the secondary endpoints.
Wulf Utian, lead investigator for the Breeze 2 trial, said: “I look forward to the results of Depomed’s Phase III trials for DM-5689 in menopausal hot flashes after having seen Depomed’s encouraging Phase II results. An effective non-hormonal and non-antidepressant treatment alternative would provide great value to patients and physicians.”