Topical ED cream gains European approval

Vitaros web The first topically applied drug for treatment of erectile dysfunction (ED) has been approved by regulatory body the European Decentralised Procedure.

Vitaros (alprostadil) cream from Takeda is now expected to gain MHRA approval for use in the UK within three months.

It will provide an alternative for many male patients who cannot tolerate PDE5 inhibitor drugs such as Viagra (sildenafil).

ED is a common consequence of ageing and several long-term conditions, and is also a common side effect of drugs such as anti-depressants and anti-hypertensives.

Vitaros is a vasodilator, boosting local blood flow at the application site, whereas oral ED drugs affect the whole circulation – often with negative side-effects.

A clinical trial in over 3,300 patients showed that topical alprostadil cream was generally well tolerated, with most side-effects being mild and of short duration – in contrast to many patients’ experience of PDE5 inhibitors.

Topical administration of Vitaros is enabled by the proprietary skin permeation-enhancing drug delivery platform NexACT, licensed by Takeda from NexMed.

“This is great news for Takeda UK and for the many men living with erectile dysfunction, and we are delighted that the UK approval of this new treatment should now be just a few months away,” said Yasuhiro Fukutomi, Managing Director, Takeda UK Ltd.

“This is an innovative new product that offers the potential to provide men with a new first line or alternative treatment option. Vitaros has been shown in clinical trials to provide rapid efficacy together with convenient local administration that is well tolerated. Takeda UK Ltd envisages that it will be a significant addition to our urology franchise.”