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Besins Healthcare launches Dimetrum® (dienogest) 2mg for the treatment of endometriosis in the UK
NOTE: This news release is intended for pharmaceutical journalists only. This news release is not intended for consumer news journalists.
24 November 2022 – Besins Healthcare announces the UK launch of Dimetrum® (dienogest) 2mg, a generic version of dienogest – a hormonal (progestin-only) therapy indicated and developed specifically for the treatment of endometriosis[1].
Dimetrum 2mg oral tablets will now be available from Besins Healthcare as a first-line hormonal progestogen treatment for patients with endometriosis[2], a chronic and often life-impacting gynaecological condition that affects an estimated 1 in 10 women (approximately 1.5 million women in the UK) of reproductive age[3].
Endometriosis is typically associated with symptoms such as pelvic pain, painful periods and subfertility. Endometriosis is also associated with a lower quality of life. Women with endometriosis report pain, which can be frequent, chronic and/or severe, as well as tiredness, more sick days, and a significant physical, sexual, psychological and social impact[2]. Despite this, patients wait an average of eight years for diagnosis in the UK[4], a delay which may contribute to disease progression. Over the next decade, the Women’s Health Strategy for England seeks to reduce the time from initial GP appointment through to diagnosis.
Dr Anne Connolly MBE, GP with a Special Interest in Gynaecology, remarked: “It’s great to see this advancement for the care of women suffering from this complex condition, with the ambition of improving the immediate menstrual symptoms and reducing the long-term complications of unmanaged disease.”
Georgina Edeke, Medical Director at Besins Healthcare UK, commented: “Endometriosis can be debilitating for sufferers, however there is poor correlation between the degree of reported symptoms and the severity of disease. Considering that around a quarter of patients are asymptomatic[5], there is an even more urgent need for education around the condition. The Women’s Health Strategy for England sets out an ambition to transform the healthcare experience for all women and girls through greater understanding and evidence. In line with this objective, we hope to increase awareness of endometriosis among primary and secondary healthcare professionals to drive timely diagnosis and effective, high-quality management.”
Dienogest is a therapeutic option for women with endometriosis when a hormone (a progestogen) is suitable. Dienogest acts on endometriosis by reducing the endogenous production of oestradiol and thereby suppresses the trophic effects of estradiol on both the eutopic and ectopic endometrium[1].
Del Cohen, Managing Director at Besins Healthcare added: “Besins Healthcare is focused on understanding how we can restore and rebalance fundamental, yet often-overlooked body processes. In response, we have developed a portfolio of evidence-based hormonal therapies. Expanding our focus to endometriosis is a natural next-step and enables us to play an enhanced role as we support education and awareness among both healthcare professionals and women suffering from endometriosis.”
-ENDS-
Notes to newsroom:
About Endometriosis
Endometriosis is defined as the growth of endometrial-like tissue (the womb lining) outside the uterus (womb). This endometrial-like tissue behaves like the uterine lining — proliferating, breaking-down, and bleeding with each menstrual cycle. The blood has nowhere to go, resulting in ‘internal bleeding’ which causes inflammation – in turn, forming scar tissue and adhesions during the repair process[6]. This typically affects the ovaries, fallopian tubes, and pelvic side wall, and in some patients, non-reproductive organs such as the bladder and bowel. Women with endometriosis typically present to community services (including GPs, practice nurses, school nurses and sexual health services) with pain, and may then be referred to gynaecology services for diagnosis and management [2].
About Besins Healthcare
Besins Healthcare is a pharmaceutical company specialising in the development of innovative medicines for the well-being of men and women throughout their life. Over the past 30 years, Besins Healthcare has established a strong and reputable name in the production of medicines for the treatment of gynaecological, fertility and obstetrical conditions as well as androgen deficiency and has become a renowned company in the area of hormonal therapies.
https://besinshealthcare.co.uk/
About Dimetrum[1]
Dimetrum is indicated for the treatment of endometriosis.
It is a nortestosterone-derivative fourth-generation progestin.
The dosage is one tablet daily without any break, taken preferably at the same time each day with some liquid as needed. The tablet can be taken with or without food. Tablets must be taken continuously without regard to vaginal bleeding.
Treatment can be started on any day of the menstrual cycle.
Any hormonal contraception needs to be stopped prior to initiation of Dimetrum. If contraception is required, non-hormonal methods of contraception should be used (e.g. barrier method).
Dimetrum is not indicated in children prior to menarche.
Dimetrum is available in the UK as a 2mg tablet, in pack sizes of 28, 84 and 168 tablets. The NHS drug tariff price is £20.50.
The Dimetrum 2mg Summary of Product Characteristics (SmPC) can be found on the electronic medicines compendium (eMC) website: www.medicines.org.uk.
Media enquiry contact details:
Louise Coxon
TALA
+44 (0) 7870 661105
louise.coxon@teamtala.com
Lex Rosenthal
TALA
+44 (0) 7912 611 432
lex.rosenthal@teamtala.com
References:
[1] Besins Healthcare (UK) Ltd. Dimetrum 2 mg Tablets - Summary of Product Characteristics (SmPC) - (emc) [Online]. www.medicines.org.uk. 2022. Available from: https://www.medicines.org.uk/emc/product/14039/smpc [Accessed 31 October 2022].
[2] National Institute for Health and Care Excellence (NICE). Endometriosis: diagnosis and management [Online]. NICE. 2017. Available from: https://www.nice.org.uk/guidance/ng73/resources/endometriosis-diagnosis-and-management-pdf-1837632548293 [Accessed 2 November 2022].
[3] NICE Clinical Knowledge Summaries (CKS). Endometriosis [Online]. 2020. Available from: https://cks.nice.org.uk/topics/endometriosis/background-information/prevalence.
[4] All Party Parliamentary Group on Endometriosis. Endometriosis in the UK: time for change. APPG on Endometriosis Inquiry Report 2020. [Online]. 2020. Available from: https://www.endometriosis-uk.org/sites/default/files/files/Endometriosis%20APPG%20Report%20Oct%202020.pdf [Accessed 31 October 2022].
[5] Bulletti C, Coccia ME, Battistoni S, Borini A. Endometriosis and infertility. Journal of assisted reproduction and genetics. 2010 Aug;27(8):441-7. Available from: doi: 10.1007/s10815-010-9436-1 [Accessed 19 October 2022].
[6] Klemmt PA, Starzinski-Powitz A. Molecular and cellular pathogenesis of endometriosis. Current women's health reviews. 2018 Jun 1;14(2):106-16. Available from: DOI: 10.2174/1573404813666170306163448 [Accessed 19 October 2022].
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