IMVEXXY Efficacy

In a 12-week, phase 3 clinical trial

Effective Dyspareunia Relief1,2

IMVEXXY demonstrated statistically significant improvement in moderate to severe dyspareunia due to menopause.1

IMVEXXY reduced moderate to severe dyspareunia due to VVA at week 12 and as early as week 2 (a secondary endpoint) (N=574)1-3

Chart: Dyspareunia severity score over 12 weeks

*P<0.05; †P<0.0001.

P value vs placebo based on mixed model repeated measures analysis.

Demonstrated Improvements in Vaginal Health1

Vaginal Microbiome Icon

Normal cytology and proper pH levels (commonly known as vaginal pH balance) are important to support vaginal health and microbiome4

Co-Primary Endpoint Icon

IMVEXXY demonstrated efficacy in 3 co-primary endpoints (change in vaginal parabasal and superficial cells and vaginal pH levels)1,2

Efficacy Study Design

Efficacy Study Design

This 12-week, randomized, double-blind, placebo-controlled, parallel-group trial enrolled 574 generally healthy postmenopausal women between 40 and 75 years of age who at baseline had ≤5% superficial cells on a vaginal smear, a vaginal pH >5.0, and self-identified moderate to severe dyspareunia as their most bothersome symptom of VVA.


Improvement in the mean change from baseline at week 12 was assessed for the co-primary efficacy variables of most bothersome moderate to severe symptom of dyspareunia, percentage of vaginal superficial and parabasal cells on a vaginal smear, and vaginal pH.1

Bio-Identical*

Molecule Icon

IMVEXXY is bio-identical* estradiol that is structurally identical to the estrogen produced in the body.2,3,5

*The relevance of risks associated with the use of synthetic hormones compared to bio-identical hormones is not known but cannot be excluded.

Indication

IMVEXXY® (estradiol vaginal inserts) is an estrogen indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.


Important Safety Information

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.

Warning 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 click here for the Full Prescribing Information, including BOXED WARNING.

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