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.

"Based on our recent interactions, we believe that data from our Serada clinical trial program warrants submission of an NDA for the FDA's review and consideration," said Jim Schoeneck, president and chief executive of Depomed, adding: "We believe Serada may offer clinical benefit as a non-hormonal treatment option for women suffering from menopausal hot flashes."