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Imvexxy Approval History

Reviewed on May 30, 2018 by J.Stewart B.Pharm.

  • FDA approved: Yes (First approved May 29th, 2018)
  • Brand name: Imvexxy
  • Generic name: estradiol
  • Dosage form: Vaginal Inserts
  • Previous name: TX-004HR
  • Company: TherapeuticsMD, Inc.
  • Treatment for: Dyspareunia

Imvexxy (estradiol) is a bio-identical 17β-estradiol vaginal insert for the treatment of dyspareunia (vaginal pain during sexual intercourse) due to menopause.

Important Safety Information

All estradiol formulations (including Imvexxy) come with a boxed warning:

  • 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

Dosage and Administration

Imvexxy should be administered intravaginally as follows: one vaginal insert daily for 2 weeks, followed by one insert twice weekly.

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.

Imvexxy Side Effects

The most common adverse reaction with Imvexxy (incidence ≥ 3 percent) and greater than placebo was headache.

Development History and FDA Approval Process for Imvexxy

DateArticle
May 30, 2018Approval TherapeuticsMD Announces FDA Approval of Imvexxy (estradiol vaginal inserts) for the Treatment of Dyspareunia Due to Menopause
Dec 19, 2017TherapeuticsMD Announces FDA Acceptance of New Drug Application and Prescription Drug User Fee Act (PDUFA) Date for TX-004HR
Nov 29, 2017TherapeuticsMD Announces Resubmission of New Drug Application for TX-004HR
May  8, 2017TherapeuticsMD Receives Complete Response Letter from FDA for TX-004HR New Drug Application
Apr 19, 2017TherapeuticsMD Provides Additional Information on TX-004HR Regulatory Update
Apr 10, 2017TherapeuticsMD Provides TX-004HR Regulatory Update
Sep 19, 2016TherapeuticsMD Announces FDA Acceptance of New Drug Application (NDA) and Prescription Drug User Fee Act (PDUFA) Date for Yuvvexy (TX-004HR)
Jul  7, 2016TherapeuticsMD Announces New Drug Application Submission for Yuvvexy (TX-004HR)

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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