Depomed (DEPO) to File NDA with FDA for Serada in H212

Depomed, Inc. (Nasdaq: DEPO) has completed a Type B pre-NDA meeting with the United States Food and Drug Administration (FDA) regarding the results of the three Phase 3 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.

In October 2011, 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 new drug application (NDA) in light of the results of the three Phase 3 trials of Serada completed by Depomed. 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.

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