Depomed, Inc. announced that it 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.
“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 officer of Depomed. “We believe Serada may offer clinical benefit as a non-hormonal treatment option for women suffering from menopausal hot flashes.”
Date: April 17, 2012
Source: Depomed, Inc.
Filed Under: Drug Discovery
