NDA filed for non-hormonal menopause therapy
This article was originally published in Scrip
Noven Pharmaceuticals has submitted a new drug application (NDA) to the US FDA seeking approval to market its investigational non-hormonal treatment for the vasomotor symptoms associated with menopause, low-dose mesylate salt of paroxetine (LDMP).
In March, the company, which is a wholly-owned subsidiary of Hisamitsu Pharmaceutical, announced the completion of the clinical development programme for LDMP, including two Phase III studies in a total of 1180 patients across the US. These data are scheduled to be presented at the North American Menopause Society Annual Meeting in October 2012.