Depomed Plans Second Phase III Serada Trial on FDA Advice

Depomed plans to file a special protocol assessment for a second Phase III trial of Serada by February, after the FDA asked for a redesigned study to demonstrate efficacy in treating menopausal hot flashes. The company is seeking the indication for an extended-release version of Serada (gabapentin). Gabapentin is approved to treat neuropathic pain and epilepsy.
Drug Industry Daily