Depomed Inc. announced today the start of the first of two key phase III clinical trials for the registration of the use of Gabapentin GR(R) in the treatment of menopausal hot flashes.

The company's phase 3 registration program for Gabopentin GR(R) in menopausal hot flashes includes two randomized, double-blind placebo-controlled studies of over 500 patients each. Patients in each study will be randomized into 3 treatment arms: placebo, 1200mg daily, and 1800mg daily (in 2 doses). Breeze 1 treatment will last 6 months and treatment duration for Breeze 2, the second study, will be 3 months. Efficacy in both will be assessed at 4 and 12 weeks. Efficacy endpoints will be decrease in severity and frequency of hot flashes as well as quality of life and continuance of efficacy after 6 months.

Published data supports Gabapentin, an FDA-approved drug for the treatment of seizures and postherpetic neuralgia, use in addressing menopausal hot flashes. It is recommended as a non-hormonal option in treating menopause-associated vasomotor symptoms (NAMS 2004).

Depomed applies its proprietary AcuForm(TM) drug delivery technology to improve existing oral medications.

Source: Depomed, Inc.