Noven is to co-promote its menopausal hot flushes treatment Brisdelle (paroxetine) with Shionogi.
Noven, a US-based subsidiary of Hisamitsu Pharmaceutical, said the deal will help extend physician awareness of Brisdelle.
Brisdelle contains 7.5mg of paroxetine, which – at a slightly higher dose – is the active ingredient in antidepressants like GlaxoSmithKline’s now off-patent Seroxat/Paxil. In common with Seroxat Brisdelle also carries a Boxed Warning about suicidality in its label.
In June the drug became the first and only FDA-approved non-hormonal treatment for moderate to severe vasomotor symptoms (VMS) associated with menopause, commonly referred to as hot flushes.
It was approved to offer an alternative to treatments that contain either oestrogen alone or oestrogen plus a progestin and subsequently launched in November and marketed and sold through Noven Women’s Health.
Now Shionogi’s women’s health sales force will promote Brisdelle in the US to a range of healthcare providers, including some primary care doctors, not currently detailed by the Noven’s specialty sales force.
Jeffrey Eisenberg, Noven’s president and CEO, said the agreement “recognises and builds upon the long-standing commitment of both companies to providing therapies to address the diverse needs of menopausal women”.
The deal, financial terms of which were not disclosed, will see Noven retain Brisdelle’s commercial rights and continue to be principally responsible for its marketing, promotion and overall commercial strategy.




