Depomed to file NDA for Serada; with Valeant sues Watson over Glumetza

US drugmaker Depomed (Nasdaq: DEPO) says that it has completed a Type B pre-New Drug Application meeting with the US Food and Drug Administration regarding the results of the three Phase III clinical trials of Serada (extended-release gabapentin tablets), Depomed's investigational gastric-retentive, extended-release formulation of gabapentin for menopausal hot flashes. Based on the results of the meeting with the FDA, Depomed intends to prepare and file a new drug application with the FDA in the second half of 2012.

Last year, Depomed announced the results of the BREEZE 3 clinical trial of Serada and also announced at that time its intention to meet with the FDA to discuss possible pathways to filing a NDA in light of the results of the three Phase III trials of Serada completed by Depomed (The Pharma Letter October 17, 2011). Efficacy data from the BREEZE 3 trial were positive and statistically significant for three of the four pre-specified primary endpoints of frequency and severity at four and 12 weeks.