Postmenopausal Canadian women with vaginal dryness

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BLAINVILLE, Quebec, Feb. 14, 2022 (GLOBE NEWSWIRE) — Duchesnay Inc., a women’s health pharmaceutical company and part of the Duchesnay Pharmaceutical Group based in Blainville, Quebec, is proud to announce the first of its new company launched treatment Owner and management team to help postmenopausal women across Canada 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 trials to treat moderate to severe dyspareunia (painful sexual intercourse) and/or vaginal dryness in postmenopausal women presenting with symptoms of vulvar and vaginal atrophy (VVA), a component of the menopausal urogenital syndrome (GSM).

“In our culture, the issue of painful sex is often ignored, but it’s a sad reality for many women, especially during the menopause,” said Dr. Michelle Jacobson, obstetrician-gynecologist and menopause specialist at Women’s College and Mount Sinai Hospital in Toronto. “Having a once-a-day treatment option to help these women and their partners is exciting news for them and their doctors. The more we can individualize the therapy, the better we can influence quality of life and functionality.”

“Consistent with Duchesnay’s longstanding commitment to women’s health, we strive to continue to 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 by new ownership team
Osphena® is the first new drug from Duchesnay since the company changed ownership last year. “As we execute the first part of the company’s strategic plan, we hope to bring two more innovative treatments to Canadian patients in the coming months. This paves the way for Duchesnay’s bright future while shifting 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), who I want to thank,” said Éric Gervais, President.

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

According to a US survey of 1,858 postmenopausal women, about half of the 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 menopausal urogenital syndrome (GSM), which is caused by significant changes in vaginal tissues resulting from local estrogen deficiency.3,4

Osphena® is a selective estrogen receptor modulator (SERM) that is thought to work in a similar way to estrogen in the vagina. It does this by increasing the thickness of the vaginal walls and restoring proper acidity in the vagina.3

Duchesnay Inc. acquired the US and Canadian rights to Osphena® from Shionogi Inc. in 2017 after it received US Food and Drug Administration approval in February 2013. Osphena® is included in the guidelines of the American College of Obstetricians and Gynecologists (ACOG)5the 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 to treat moderate to severe dyspareunia and/or vaginal dryness, symptoms of vulvar and vaginal atrophy (VVA), a component of genitourinary syndrome of menopause (GSM), authorized. . It is taken orally once a day with a meal.3

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

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

Health Canada’s approval of Osphena® was based on the results of four multi-center, randomized, double-blind, placebo-controlled, parallel-group clinical trials that demonstrated a statistically significant improvement in Osphena®-treated women compared to placebo.3

About Duchesnay Pharmaceutical Group
The Duchesnay Pharmaceutical Group and its affiliates are headquartered in Blainville, Quebec. The group consists of five pharmaceutical companies to meet the needs of patients in Canada, the US 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, a US generics company specializing in approved generic and orphan drugs. From its state-of-the-art production facility, Duchesnay is able to export its innovative treatments to more than 50 countries.

Duchesnay and Medunik, through proprietary R&D and partnerships, provide innovative treatments for a wide range of conditions in the fields of women’s health, urology, oncology and rare diseases. The group of companies recognizes the commitment and professionalism of its employees and promotes a positive culture and flexible work environment. It is strongly committed to environmental stewardship and gives back to the community by supporting various charities. Visit duchesnay.com, medunik.com and analogpharma.com for more information.

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 EMPOWER survey of women: exploring women’s perceptions of vulvar and vaginal atrophy and their management. J Sex Med 2017;14:413-24.
  3. Duchesnay Inc., Osphena® Product Monograph, July 2021.
  4. The Genitourinary Syndrome of Menopause 2020 North American Menopause Society Position Statement. Menopause: The Journal of The North American Menopause Society 2020;27(9):976-992
  5. Kaunitz AM and Manson JE, Management of menopausal symptoms, Obstetrics Gynec. Oct 2015; 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, Menopausal Urogenital Syndrome/ Symptomatic Vulvovaginal Atrophy, Clinical Care Recommendations, No. 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 #422d: Menopause and Sexuality, Journal of Obstetrics and Gynecology Canada (JOGC)09/15/2021, 09/15/2021, DOI: https://doi.org/10.1016/j.jogc.2021.09.00, https://www.jogc.com/article/S1701-2163(21 )00693-9/ full text

For media inquiries:
Sabrina Sevigny
Capital Image, for the Duchesnay Pharmaceutical Group
[email protected]
Cell: (514) 991-4148

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