Imvexxy 4 mcg dose now commercially available in
“We are incredibly excited to launch the 4 mcg dose of Imvexxy, which is
the lowest dose vaginal estradiol product approved by the
For postmenopausal women with VVA, Imvexxy provides improvement in moderate-to-severe dyspareunia within 12 weeks, and beginning as early as two weeks for some women, which was a secondary endpoint in the pivotal Phase 3 clinical trial of Imvexxy. In general, women should begin treatment at the 4 mcg dose, and may consider the 10 mcg dose depending on their clinical response. Imvexxy is inserted about two inches into the vagina to re-estrogenize the tissue in and around the vagina. Imvexxy is administered daily for two weeks followed by only twice a week dosing to maintain treatment.
About Dyspareunia and Vulvar and Vaginal Atrophy (VVA)
VVA is a component of genitourinary syndrome of menopause (GSM), which may include, but is not limited to, genital symptoms of dryness, burning and irritation, sexual symptoms such as decreased lubrication, discomfort, and pain, and urinary symptoms such as urgency, dysuria, and recurrent urinary tract infections.1 VVA is a chronic, progressive condition that leads to distressing symptoms and can progressively worsen if not treated.2
VVA is a condition that develops when the body makes less estrogen due to menopause. Without sufficient estrogen, the vaginal tissue becomes thin, dry, and less elastic. The vaginal canal can also narrow and shorten. Insufficient estrogen can also decrease vaginal fluids, change the acid balance of the vagina, and weaken pelvic floor muscles. All these factors can lead to dyspareunia.3
VVA affects an estimated 32 million postmenopausal women in the US.4 Only about seven percent (2.3 million) of these women receive prescription treatment. Nearly one out of two women will experience pain during intercourse due to VVA at some point during their postmenopausal years.5
About Imvexxy
Imvexxy (estradiol vaginal inserts) is approved in the U.S. for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Imvexxy is the only product in its therapeutic class to offer a 4 mcg and 10 mcg dose, the 4 mcg dose representing the lowest approved dose of vaginal estradiol available. The full prescribing information may be viewed by visiting www.Imvexxy.com.
IMPORTANT SAFETY INFORMATION FOR IMVEXXY
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER
and PROBABLE DEMENTIA
See full prescribing information
for complete boxed warning.
Estrogen-Alone Therapy
- There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens
- Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia
- The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT)
- The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older
Estrogen Plus Progestin Therapy
- Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia
- The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE) and myocardial infarction (MI)
- The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer
- The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older
CONTRAINDICATIONS
- Imvexxy™ is contraindicated in women with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active DVT, PE, or history of these conditions; active arterial thromboembolic disease or a history of these conditions; known anaphylactic reaction or angioedema to Imvexxy; known liver impairment or disease; known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.
WARNINGS AND PRECAUTIONS
- Imvexxy is intended only for vaginal administration. Systemic absorption may occur with the use of Imvexxy.
- The use of estrogen-alone and estrogen plus progestin therapy has been reported to result in an increase in abnormal mammograms requiring further evaluation.
- The WHI estrogen plus progestin substudy reported a statistically non-significant increased risk of ovarian cancer. A meta-analysis of 17 prospective and 35 retrospective epidemiology studies found that women who used hormonal therapy for menopausal symptoms had an increased risk for ovarian cancer. The exact duration of hormone therapy use associated with an increased risk of ovarian cancer, however, is unknown.
- Other warnings include: gallbladder disease; severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice.
- Estrogen therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.
- Women on thyroid replacement therapy should have their thyroid function monitored.
ADVERSE REACTIONS
- The most common adverse reaction with Imvexxy (incidence ≥ 3 percent) and greater than placebo was headache.
Please note that this information is not comprehensive. Please visit www.Imvexxy.com for the Full Prescribing Information, including the Boxed WARNING.
Forward-Looking Statements
This press release by
1 Portman DJ, Gass ML;
2
3
4 Wysocki S, Kingsberg S, Krychman M. Management of vaginal
atrophy: Implications from the
5
View source version on businesswire.com: https://www.businesswire.com/news/home/20180913005126/en/
Source:
TherapeuticsMD, Inc.
Nichol Ochsner, 561-961-1900, ext. 2088
Vice
President Investor Relations
Nochsner@TherapeuticsMD.com