Noven files NDA for non-hormonal therapy for menopausal vasomotor symptoms

USA-based Noven Pharmaceuticals, a wholly-owned subsidiary of Japanese drugmaker Hisamitsu Pharmaceuticals (TYO: 4530), has submitted a New Drug Application with the US Food and Drug Administration seeking approval to market low-dose mesylate salt of paroxetine (LDMP) for the treatment of vasomotor symptoms associated with menopause.

In March 2012, Noven announced completion of the LDMP clinical development program, which included two Phase III studies involving an aggregate of 1,180 subjects from more than 130 centers across the USA. Phase III study results for LDMP are scheduled to be presented at the North American Menopause Society Annual Meeting in October 2012.

Paroxetine is the active ingredient of GlaxoSmithKline’s antidepressant Paxil/Seroxat.