NDA Submitted for Serada for Menopausal Hot Flashes
Depomed announced that it has submitted a New Drug Application (NDA) for Serada to the FDA, seeking approval for the treatment of menopausal hot flashes.
Depomed has conducted three Phase 3 studies evaluating Serada for menopausal hot flashes. Breeze 3 was completed in 2011. Breeze 1 and Breeze 2 were completed in 2009.
Serada is a proprietary extended-release formulation of gabapentin. Scientists hypothesize that gabapentin may reduce hot flashes by regulating the flow of calcium in and out of cells, which is one mechanism for controlling body temperature.
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