Depomed initiates Phase III menopausal hot flashes program

Depomed’s Phase III registration program for Gabapentin GR in menopausal hot flashes includes two randomized, double-blind, placebo-controlled studies of approximately 540 patients per study.

In each study, patients will be randomized into one of three treatment arms – the first group receives placebo, the second group 1200mg of Gabapentin GR dosed once daily, and the third group a total dose of 1800mg of Gabapentin GR dosed 600mg in the morning and 1200mg in the evening.

The primary efficacy endpoints in both studies will be reductions in the mean frequency of moderate-to-severe hot flashes, and the average severity of hot flashes, measured after four and 12 weeks of stable treatment. Various secondary efficacy endpoints including quality of life will be measured as well.

The treatment duration of the Breeze 1 study will be six months, with primary efficacy endpoints assessed at four and 12 weeks. Persistence of efficacy will be assessed at six months as one of the secondary endpoints. The treatment duration in the second study, Breeze 2, will be three months, with assessment of efficacy at four and 12 weeks only. Breeze 2 is expected to begin in the fourth quarter of 2008.

Carl Pelzel, president and CEO of Depomed, said: “With Gabapentin GR’s potential for a high degree of unique differentiation versus the standard of care and its patent exclusivity, these Phase III clinical trials represent a major step toward building the value of our late-stage pipeline.”