Duchesnay Inc. is seeking Health Canada approval for a segesterone acetate/ethinyl estradiol contraceptive vaginal system, a new option for women
With its long-acting properties, this product is another step toward bringing contraceptive choice, convenience and control to women around the world.
BLAINVILLE, Quebec, Nov. 30, 2023 (GLOBE NEWSWIRE) -- Duchesnay Inc., member of Duchesnay Pharmaceutical Group (DPG) one of the few anchor companies selected by the Government of Canada for its Global Hypergrowth Project, has recently filed a New Drug Submission (NDS) to Health Canada for its segesterone acetate / ethinyl estradiol slow-release vaginal system developed for contraception control. With its long-acting properties, this product is another step toward bringing contraceptive choice, convenience and control to women around the world.
RingzaTM * is a soft reusable silicone vaginal ring which combines two hormones, a novel progestin (segesterone acetate) and a widely used estrogen (ethinyl estradiol), which are diffused at a slow, steady rate in the bloodstream. A key attribute of this system is the fact that it can be inserted and removed by the woman herself and is designed to be used for up to 13 cycles (one year).
This NDS is the natural continuation of DPG’s many recent launches in women's health in Canada and is also a prelude to more than 4 new contraceptive products DPG hopes to release in the future, thereby showcasing the company’s unique position in this field. “DPG continues to be a leader in contraception and women’s health care with this submission in Canada and is committed to the continuous evaluation of other novel options,” said Michael Gallo, Vice-President of Regulatory and Medical Affairs at Duchesnay Pharmaceutical Group. “With the approval of Slynd in 2021, an estrogen-free birth control pill, RingzaTM * is the second contraceptive that we expect to launch on the Canadian market and our first collaboration with the experts of the Population Council.”
In 2018, the Population Council, a global nonprofit research organization, secured United States Food and Drug Administration (FDA) approval for this product, a first in a new class of contraceptives, which has since been commercialized in the United States. In 2020, Duchesnay Inc. acquired the global rights** to make this product available on all continents and pursues its close collaboration with the world-renowned organization to continually expand its innovative therapeutic offerings.
“Our partnership with Population Council and the submission of this novel contraceptive method is in line with our research interests and global expansion efforts. I am proud to work for an organization dedicated to providing women with accessible, efficient options that will give them more control over their destinies” said Suzanne Paszkiewicz, Vice-President of Global Partnerships and Strategic projects at Duchesnay Pharmaceutical Group.
In keeping with its commitment to women's health at all stages of their lives, DPG collaborators are working tirelessly to launch this new contraceptive option in the second half of 2024 upon Health Canada approval, for the benefit of Canadian women and is further exploring opportunities to obtain regulatory approval in other parts of the world.
The product’s safety and efficacy are still under investigation of Health Canada and marketing authorization has not yet been granted.
* Commercial name pending approval.
** Worldwide rights held by DPG exclude the USA.
ABOUT DUCHESNAY
Duchesnay is a specialty pharmaceutical company with a long-standing commitment to women’s health. Until recently, the company focused on filling the void in terms of scientific research and education and on developing pharmacological solutions that are safe and effective for use during pregnancy and breastfeeding.
Today, Duchesnay has broadened its portfolio of products to offer safe and effective therapeutic options that meet the health and quality of life needs of women and their family members at different stages of their lives. Believing that women around the world deserve to have access to specialized treatments for their conditions, Duchesnay now distributes its products on three continents. For more information about Duchesnay, please visit https://duchesnay.com/en/.
ABOUT DUCHESNAY PHARMACEUTICAL GROUP
Duchesnay Pharmaceutical Group (DPG), 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 United States and abroad. The companies are Duchesnay (Canada) 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, DPG exports its innovative treatments to more than 50 countries. DPG is one of the 8 companies across the country chosen to participate in the Government of Canada's Global Hypergrowth Project. This appointment offers exclusive and personalized support for at least 2 years, in order to accelerate our growth to become an anchor firm in the Canadian economy.
The Group, through its proprietary research and development, and through exclusive partnerships, offers innovative treatments for a variety of medical conditions in women's health, urology, oncology as well as for rare diseases. DPG 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 to giving back to the community through the support of various charitable organizations. For more information, please visit https://duchesnaypharmaceuticalgroup.com/en.
References:
- The Nestorone®/Ethinyl Estradiol One-Year Vaginal Contraceptive System, https://popcouncil.org/project/the-nestorone-ethinyl-estradiol-one-year-vaginal-contraceptive-system/
- FDA approves new vaginal ring for one year of birth control, https://www.fda.gov/news-events/press-announcements/fda-approves-new-vaginal-ring-one-year-birth-control
Media contact:
Mariia Savchuk
Senior Advisor, Communications
[email protected]
+1 (450) 433-7734
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b848c9cc-9487-45a0-a9ba-286af25c1a54
