Gedeon Richter launches Vagirux® (estradiol hemihydrate) in the UK for treatment of vaginal atrophy in postmenopausal women

• Availability of Vagirux® (estradiol hemihydrate) allows the NHS to offer an alternative, localised hormone replacement therapy (HRT) to postmenopausal women living with vaginal atrophy1

• Vaginal atrophy affects up to half of postmenopausal women and can significantly impact a woman’s quality of life2,3

• Estradiol hemihydrate has an applicator which can be used up to 24 times, helping reduce the volume of medicinal plastics going to landfill and incineration, in line with the NHS Long Term Plan1,4

London, 07 December 2020 – Gedeon Richter Plc. (“Richter”) today announced the UK availability of Vagirux® (estradiol hemihydrate) for the treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women with or without a uterus.1 Estradiol hemihydrate vaginal tablets are applied with a reusable applicator to help reduce the volume of single-use plastics, in line with the NHS Long Term Plan setting.1,4

Dr Kathrine Scott, Medical Director at Gedeon Richter UK, said: “The launch of estradiol hemihydrate offers healthcare professionals and patients additional options for treatment. Vaginal atrophy can impact a woman’s quality of life in a number of ways and we hope that this treatment helps to reduce the burden they may face.“

Vaginal atrophy occurs when the vaginal walls become thinner and dryer due to low levels of oestrogen.2,3 This atrophy most commonly occurs during or after the menopause and can affect up to one in three women.2 Symptoms of the condition include burning sensations in the vagina, urinary incontinence and painful sexual intercourse, all of which can impact a woman’s quality of life and interfere with relationships.2,3 It is estimated that up to half of postmenopausal women will not visit their doctor, due to embarrassment or believing it is ‘normal‘.2,5

Estradiol hemihydrate is a targeted, localised hormone-replacement therapy (HRT) that has shown significant improvements in its clinical trial primary endpoints, including relief of moderate / severe urogenital symptoms considered most bothersome by participants.1 The applicator can be used up to 24 times before disposal, which can help reduce the volume of medicinal plastics going to landfill and incineration, in line with the NHS Long Term Plan.4,5

“We are very pleased to have launched estradiol hemihydrate in the UK, and hope it will have a positive impact on those women living with vaginal atrophy,“ said Tamás Neubauer, Managing Director at Gedeon Richter UK. “We are committed to ensuring a robust supply chain, especially during the pandemic. We have processes in place to mitigate the risk of any interruptions to supply in the UK with transportation using Gedeon Richter’s own system, removing reliance on other companies, along with maintaining seven months‘ stock, reducing any risk to supply issues.“

About estradiol hemihydrate

Estradiol hemihydrate is a 10 microgram vaginal tablet containing estradiol (as estradiol hemihydrate) indicated for the treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women, with or without a uterus.1 The experience in treating women over 65 years is limited.1 The initial dose should be one vaginal tablet a day for two weeks, and then one tablet twice a week thereafter.1 Estradiol hemihydrate is administered intravaginally as a local oestrogen therapy by use of an applicator.1 Please refer to the patient information leaflet for instruction on how to administer estradiol hemihydrate.

For further information, the estradiol hemihydrate Summary of Product Characteristics is available here: https://www.medicines.org.uk/emc/product/11752/smpc#gref

About Gedeon Richter

Gedeon Richter has its headquarters in Budapest, Hungary, with UK offices based in London. It is a

multinational pharmaceutical company that specialises in women’s health. The company's products

are distributed in more than 100 countries and it employs around 11,000 people worldwide.

Women’s Healthcare is a priority for Gedeon Richter, the company has several decades of extensive

experience in this area and offers a comprehensive gynaecological portfolio.

For more information visit our UK website: Gedeonrichter.co.uk