Ospemifene

TUESDAY, Sept. 10, 2024 -- Vaginal estrogen, vaginal dehydroepiandrosterone (DHEA), oral ospemifene, and vaginal moisturizers may be beneficial for some genitourinary symptoms of menopause (GSM), according to a review published online Sept. 10 in the Annals of Internal Medicine . Elisheva R. Danan, M.D., M.P.H., from the University of Minnesota in Minneapolis, and colleagues examined the effectiveness and harms of vaginal estrogen, nonestrogen hormone therapies, and vaginal moisturizers for treatment of GSM in a systematic review of randomized controlled trials (RCTs). A total of 46 RCTs assessing vaginal estrogen, nonestrogen hormones, vaginal moisturizers, or multiple interventions were identified from 11,993 citations. The researchers found that vaginal estrogen may improve vulvovaginal dryness, dyspareunia , the most bothersome symptom, and treatment satisfaction compared with placebo or no treatment. Vaginal DHEA may improve dryness, dyspareunia, and distress, bother, or interference from genitourinary symptoms compared with placebo; oral ospemifene may improve dryness, dyspareunia, and treatment satisfaction; and dryness may also be improved by vaginal moisturizers (all low certainty of evidence [COE]). No benefit or uncertain effects (low and very low COE, respectively) may be provided by vaginal testosterone, systemic DHEA, vaginal oxytocin, and oral raloxifene or bazedoxifene. Reporting was limited by studies of short duration that were insufficiently powered to assess infrequent serious harms. "Future studies would be strengthened by standard definitions of symptoms and uniform diagnostic criteria for GSM, a common set of validated outcome measures and reporting standards, and attention to clinically relevant patient populations and intervention comparisons," the authors write.

BLAINVILLE, Quebec, June 21, 2022 (GLOBE NEWSWIRE) -- Duchesnay Inc., a pharmaceutical company specializing in women’s health and part of Duchesnay Pharmaceutical Group headquartered in Blainville, Quebec, is pleased to announce that it has launched its newest treatment, Vablys® (dequalinium chloride vaginal tablets). Vablys® is the first prescription antiseptic and anti-infective treatment for bacterial vaginosis in women under 55 years of age. With its multiple modes of action and anti-infective properties against a wide range of pathogens, a treatment course of Vablys® consists of one tablet inserted in the vagina at bedtime for six consecutive days. “Vablys® offers Canadian physicians and their patients the first gynecological anti infective and antiseptic prescription treatment option,” said Gino Henry, Senior Manager, Commercial Affairs, at Duchesnay. “We’re convinced that our product provides a new and effective way to treat this condition.” 1 Vablys® is the third new prescription treatment for Canadian women launched by Duchesnay in 2022, achieving an aggressive target set by the company’s new management team. The other two new treatments are the contraceptive Slynd® (drospirenone), a progestin-only pill (POP) which offers a 24-hour safe window for a missed pill, during which no other contraception is needed to prevent pregnancy, and Osphena® (ospemifene tablets), a selective estrogen receptor modulator (SERM) approved by Health Canada as a once-daily prescription treatment for postmenopausal women to treat vaginal dryness and painful intercourse. “Duchesnay is very proud to have achieved its ambitious target of bringing three new innovative prescription treatments to Canadian women in the first six months of 2022, a key element of our growth plans under our new management team,” said Dany Hallé, Vice-President, Commercial Affairs at Duchesnay. “All three new treatments address important needs for women at different stages of their lives and demonstrate concretely the commitment of Duchesnay to providing women’s health solutions. We look forward to continuing to do so.” The Health Canada-approved product monographs for Vablys®, Slynd® and Osphena® are available on the Duchesnay website at . They give contraindications, warnings, precautions, adverse reactions, interactions, dosing and conditions of clinical use. The product monographs are also available through the Duchesnay Medical Information Department, 1-888-666-0611 or medicalinfo@duchesnay.com. About bacterial vaginosis Bacterial vaginosis (BV) is an imbalance of the naturally-occurring, healthy bacteria found in the vagina or internal genitals. This imbalance can cause symptoms that may include more vaginal discharge than usual, a fish-like smell or irritation in the vaginal area2, though often symptoms are not noticed. According to the Public Health Agency of Canada, bacterial vaginosis is the most common cause of vaginal discharge in people of reproductive age. Bacterial vaginosis is not usually considered sexually transmitted, but it is associated with increased acquisition of human immunodeficiency virus (HIV), human papilloma virus (HPV) and Chlamydia trachomatis (CT).3 About Duchesnay Pharmaceutical Group 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 Duchesnay Inc., Vablys® Product Monograph, September 2021. British Columbia Centre for Disease Control, Bacterial Vaginosis, Health Canada, STI-associated syndromes guide: Vaginitis, Public Health Importance, September 2021, Media contact: Email: info@duchesnay.com Telephone: (877) 833-7734 A photo accompanying this announcement is available at Vablys Vablys