New transdermal hormone replacement therapy spray becomes available in the UK – PharmiWeb.com

London, United Kingdom 15 April 2020 Gedeon Richter Plc. (Richter) today announced the UK availability of their new hormone replace therapy (HRT), Lenzetto (estradiol spray), for symptoms of oestrogen deficiency in post-menopausal women, at least six months since last menses or surgical menopause, with or without a uterus.1 Estradiol spray is applied to the skin and is specifically designed to be delivered as an oestrogen spray. 1

Dr Kathrine Scott, Medical Director at Gedeon Richter UK, said: Gedeon Richter are very pleased to be able to offer this new HRT, which we hope gives more options to healthcare professionals and women. The availability of estradiol spray means that women who are experiencing menopausal symptoms have a greater variety of potential treatments that could improve their quality of life.

Around 13 million women in the UK are either peri- or post-menopausal, and symptoms can last up to 15 years.2 In a study conducted by Nuffield Health, it was found that 60% of women experience symptoms resulting in behaviour changes with two thirds of women feeling that there is a general lack of support or understanding.[ii]

In clinical studies, estradiol spray has met its primary endpoint of mean change from baseline for both the frequency and severity of hot flushes, with adverse events reported comparable to other transdermal products.[iii] Estradiol spray has also met pharmacological endpoints, with the product delivering estradiol at a therapeutic level.[iv]

The decision to make estradiol spray available on the NHS is a positive step for both patients and clinicians, said Tams Neubauer, Managing Director at Gedeon Richter. We are excited about this new treatment being made available across the UK, and hope it has a positive impact for women.

About estradiol spray

Estradiol spray is a metered-dose transdermal spray (MDTS) that delivers 90 microlitres of spray solution containing 1.53 mg of estradiol.1 It is administered once daily either as monotherapy or as a continuous sequential treatment, when combined with a progestogen. 1

The dose may be increased to two metered-dose sprays daily to the forearm based on

clinical response. 1 Dose increases should be based on the degree of the womans menopausal symptoms and should be made only after at least four weeks of continuous treatment with estradiol spray. The maximum daily dose is 3 metered-dose sprays (4.59 mg/day) to the forearm. 1 Dose increase should be discussed with the physician before any changes are made.

Estradiol is the major oestrogenic hormone secreted by the ovaries and its levels decrease during the menopause.[v] Estradiol spray provides an oestrogen replacement through synthetic estradiol, which is chemically and biologically equivalent to human estradiol.1

Estradiol spray is indicated for oestrogen deficiency symptoms in postmenopausal women, at least 6 months since last menses or surgical menopause, with or without a uterus. 1 The experience in treating women older than 65 years is limited. 1

About menopause

The menopause is a natural part of aging for women, with the average age for women to reach the menopause being 51.[vi] The menopause occurs when a womans natural oestrogen levels decline and, this causes symptoms such as hot flushes, night sweats, vaginal dryness and low mood or anxiety.

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 womens health. The company's products are distributed in more than 100 countries and it employs around 11,000 people worldwide. Womens Healthcare is a priority for Gedeon Richter, the company has several decades of extensive experience in this area and offers a comprehensive gynaecological portfolio.

[i] EMC. Lenzetto 1.52mg/spray, transdermal spray, solution. Available at: https://www.medicines.org.uk/emc/product/11175/smpc. Last accessed: April 2020.

[ii] Menopause support. Facts. Available at: https://menopausesupport.co.uk/?page_id=60. Last accessed: April 2020.

[iii] Buster JE, Koltun WD, Pascual ML, Day WW, Peterson C. Low-dose estradiol spray to treat vasomotor symptoms: a randomized controlled trial. Obstet Gynecol. 2008;111:1343-1351.

[iv] Morton TL, Gattermeir DJ, Petersen CA, Day WW, Schumacher RJ. Steady-state pharmacokinetics following application of a novel transdermal estradiol spray in healthy postmenopausal women. J Clin Pharmacol. 2009;49:1037-1046.

[v] You and your Hormones. Oestrodiol. Available at: https://www.yourhormones.info/hormones/oestradiol/ Last accessed: April 2020.

[vi] NHS. Menopause Overview. Available at: https://www.nhs.uk/conditions/menopause/. Last accessed: April 2020.

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New transdermal hormone replacement therapy spray becomes available in the UK - PharmiWeb.com