Estradiol to switch to OTC in UK?

The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has launched a consultation on proposals to reclassify Danish-based Novo Nordisk’s Gina (estradiol 10mcg) vaginal tablets. This would mean that for the first time, women in the UK could access a local hormone replacement therapy at a pharmacy without a prescription. The tablets treat vaginal atrophy, which can cause dryness, soreness, itching, burning and painful intercourse. It affects around half of post-menopausal women, but many do not discuss the problem with their doctor.

The consultation seeks views from general practitioners, pharmacists and the public on making Gina available OTC to women aged 50+ years who have not had a period for at least one year. The MHRA stressed that as this is the first time such a change has been considered, it is important that as many opinions as possible are heard.

Proposed labelling for Gina. Source: MHRA

Nicholas Hall’s Touchpoints: When I read this story, my first reaction was concern about the safety profile of a consumer version of this formulation. I’m reassured by the Commission on Human Medicine’s statement that “it is safe for this product to be made available as a Pharmacy (P) medicine”, but I can fully understand why the MHRA is consulting widely. In fact, there seems to be a decent measure of consumer and professional support for the switch as far as I can tell.

Coming hard on the heels of last year’s switch of the daily oral contraceptive in the UK, Novo Nordisk’s Gina – if approved – will be launched into an important intersection of sexual and women’s health. Women are responsible for 60% of CHC consumption globally, but with relatively few specific products designed for them, and account for about 85% of purchasing. It also reminds us that the UK is now the premier switch market in the world, at a time when our industry’s interest in switch is at an all-time low.

For a more detailed consideration of the consultation process and the pro’s and con’s of this switch, please read CHC.NewDirections. The markets for contraception, intimate care, pregnancy and fertility products, among others, are also explored in our newly-published Sexual Health & Fertility report. For further details, or to place your order, please contact melissa.lee@NicholasHall.com.

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