Galen's IVR product approved in the UK

Galen Holdings has been granted clearance in the UK to market itsestradiol-based intravaginal ring product as a hormone replacement therapy to relieve symptoms in post-menopausal women. This is the first approval for a product based on the firm's IVR technology, which can be used to deliver a wide range of medicines for up to three months.

Galen has already enlarged its UK sales organization in anticipation of this approval, and now has 115 representatives ready to detail the product. The registration will also enable the company to seek European Union-wide regulatory approval via the mutual recognition procedure. Meanwhile, the firm says it remains on track to file a New Drug Application for the product in the USA in the middle of this year, having completed enrollment into a Phase III vasomotor study which is required for approval by the Food and Drug Administration.

The technology is also being used to develop a combined estradiol/norethisterone acetate IVR for HRT and a testosterone product for patients in whom sexual motivation is desired, as well as a contraceptive device and a product for infection control.