Postmenopausal Canadian women experiencing vaginal dryness and painful intercourse have a new oral once-daily prescription treatment, Osphena® (ospemifene tablets) from Duchesnay

BLAINVILLE, Quebec, Feb. 14, 2022 (GLOBE NEWSWIRE) -- Duchesnay Inc., a pharmaceutical company specializing in women's health and part of the Duchesnay Pharmaceutical Group based in Blainville, Quebec, is proud to announce the first treatment launched by its new ownership and management team to help postmenopausal women across Canada who are suffering from vaginal dryness and painful intercourse.

Osphena® (ospemifene tablets), a Selective Estrogen Receptor Modulator (SERM) now available across Canada, has been approved by Health Canada as a once-daily prescription treatment for this indication.

Osphena® has been shown in phase II and III clinical studies to treat moderate to severe dyspareunia (painful intercourse) and/or vaginal dryness in postmenopausal women, which are symptoms of vulvar and vaginal atrophy (VVA), a component of genitourinary syndrome of menopause (GSM).

"In our culture, the issue of painful sex is often ignored but it is a sad reality for many women, particularly in menopause," said Dr. Michelle Jacobson, an obstetrician, gynecologist and menopause specialist at Women's College and Mount Sinai Hospital in Toronto. "Having a once-daily treatment option to help these women and their partners is exciting news for them and their physicians. The more we can individualize therapy, the better we can impact quality of life and functioning."

"In line with Duchesnay's long-lasting commitment to women's health, we strive to further consolidate treatment options for physicians, and are pleased to bring this important new therapy to Canadian women who are experiencing these debilitating symptoms due to VVA," said Dany Hallé, Vice-President, Commercial Affairs, Duchesnay Inc. "Osphena® has been available from Duchesnay USA for several years where it has been both commercially successful and well received."

First product launch from new ownership team

Osphena® is the first new treatment originating from Duchesnay since a change of ownership of the company last year. "As we deploy the first part of the company's strategic plan, we are hoping to bring two other innovative treatments to Canadian patients in the coming months. This paves the way of Duchesnay's bright future while changing paradigms around women's health, all made possible with the support of our partners at Business Development Bank of Canada (BDC) and Bank of Montreal (BMO) whom I wish to thank," said Éric Gervais, President.

Common menopausal symptoms

Dyspareunia and vaginal dryness are among the most common and bothersome symptoms of VVA due to menopause, which impacts approximately half of postmenopausal women. Before menopause, estrogen helps maintain the thickness, elasticity and lubrication of vaginal tissues. However, as women age, estrogen levels drop, causing changes in these tissues, which can lead to dryness, itching, burning and painful intercourse.¹

According to a U.S. survey of 1,858 postmenopausal women, approximately half of participants rated the severity of vaginal dryness and dyspareunia (painful intercourse), the two most common bothersome moderate-to-severe symptoms of VVA.² Both conditions are components of Genitourinary Syndrome of Menopause (GSM), caused by significant changes to vaginal tissues secondary to local estrogen deficiency.^3,4

Osphena® is a Selective Estrogen Receptor Modulator (SERM) that is believed to work in a similar way as estrogen in the vagina. It does this by increasing the thickness of the vaginal walls and restoring appropriate levels of acidity in the vagina.³

Duchesnay Inc. acquired the U.S. and Canadian rights to Osphena® from Shionogi Inc. in 2017, after it had been approved by the U.S. Food and Drug Administration in February 2013. Osphena® is included in the guidelines issued by the American College of Obstetricians and Gynecologists (ACOG)⁵, the North American Menopause Society (NAMS)⁶ and the Society of Obstetricians and Gynecologists of Canada (SOGC).⁷

About Osphena® (ospemifene tablets)

Osphena® (ospemifene tablets) is approved by Health Canada for use in postmenopausal women for the treatment of moderate to severe dyspareunia and/or vaginal dryness, symptoms of vulvar and vaginal atrophy (VVA), a component of genitourinary syndrome of menopause (GSM). It is taken orally, once daily with food.³

Osphena® is contraindicated in women with any of the following conditions: known hypersensitivity to ospemifene, any of the tablet or container components; undiagnosed abnormal genital bleeding; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism or a history of these conditions; active arterial thromboembolic disease (for example, stroke and myocardial infarction) or a history of these conditions; severe hepatic impairment; pregnant or may become pregnant.³

Taking Osphena can increase the risk of developing a thromboembolic stoke (artery is blocked by blood clot), a hemorrhagic stroke (bleeding in your brain from a torn blood vessel) and deep vein thrombosis (blood clot in the deep veins of the leg or arm). There is a potential increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens.³

The Health Canada approval of Osphena® was based on the results of four multi-centre, randomized, double-blind, parallel group, placebo-controlled clinical studies which showed statistically significant improvement in women treated with Osphena® versus placebo.³

About the Duchesnay Pharmaceutical Group

The Duchesnay Pharmaceutical Group, with its affiliated companies, is headquartered in Blainville, Quebec. The group consists of five pharmaceutical companies to meet the needs of patients in Canada, the U.S., and abroad. The companies are Duchesnay and Duchesnay USA, both dedicated to women's health; Médunik Canada and Medunik USA, which provide treatments for rare diseases; and Analog Pharma, an American generic drugs company, specializing in authorized generics and orphan drugs. From its state-of-the-art manufacturing plant, Duchesnay can export its innovative treatments to more than 50 countries.

Duchesnay and Medunik, through their proprietary research and development, and through partnerships, offer innovative treatments for a variety of medical conditions in women's health, urology, oncology as well as for rare diseases. The group of companies recognizes the dedication and professionalism of its employees and promotes a positive culture and flexible work environment. It is deeply committed to environmental responsibility and giving back to the community through the support of various charitable organizations. For more information, please visit duchesnay.com, medunik.com and analogpharma.com.

References

1. International Society for Sexual Medicine, What is vulvar and vaginal atrophy (VVA)? https://www.issm.info/sexual-health-qa/what-is-vulvar-and-vaginal-atrophy-vva/
2. Kingsberg SA et al. The women's EMPOWER survey: Identifying women's perceptions on vulvar and vaginal atrophy and its treatment. J Sex Med 2017;14:413-24.
3. Duchesnay Inc., Osphena® Product Monograph, July 2021.
4. The 2020 genitourinary syndrome of menopause position statement of The North American Menopause Society. Menopause: The Journal of The North American Menopause Society 2020;27(9):976-992
5. Kaunitz AM and Manson JE, Management of Menopausal Symptoms, Obstet Gynecol. 2015 Oct; 126(4): 859–876, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4594172/
6. Shifren JL et al, The North American Menopause Society Recommendations for Clinical Care of Midlife Women, Menopause: The Journal of The North American Menopause Society, Vol. 21 No. 10, 2014, Genitourinary Syndrome of Menopause / Symptomatic Vulvovaginal Atrophy, Recommendations for Clinical Care, #4, p. 8, http://www.menopause.org/docs/default-source/2014/nams-recomm-for-clinical-care.pdf
7. Wolfman W, Krakowsky Y and Fortier M, Guideline No. 422d: Menopause and Sexuality, Journal of Obstetrics and Gynaecology Canada (JOGC), Sept. 15, 2021, Sept. 15, 2021, DOI: https://doi.org/10.1016/j.jogc.2021.09.00, https://www.jogc.com/article/S1701-2163(21)00693-9/fulltext 
   
   
   
   

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