FDA Approves New Dyspareunia Treatment

The US Food and Drug Administration has approved Imvexxy (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia, a symptom of vulvar and vaginal atrophy (VVA) due to menopause.

Imvexxy is the only product in its class that is available in a 4 mcg and 10 mcg dose. The 4-mcg dose is currently the lowest approved dose of vaginal estradiol available.

“Imvexxy is a bio-identical vaginal estrogen product that offers a fraction of the estrogen contained in the average doses of many existing products currently on the market,” said Brian Bernick, MD, Chief Clinical Officer of TherapeuticsMD, in a press release.

“Imvexxy is the only product specifically designed to be applicator-free,” Dr Bernick continued. “It dissolves completely without mess or additional clean-up, and can be used any time of day. It allows women the freedom to immediately return to their normal daily activities.”

The product was approved following the success of a Phase 3, randomized, double-blind, placebo-controlled study. Both doses of Imvexxy were associated with pain relief as early as week 2 compared with placebo.

Furthermore, in a substudy of the REJOICE trial, both doses of Imvexxy were associated with a mean concentration of estradiol and estrone within the average postmenopausal range.

The most commonly reported adverse reaction with Imvexxy was headache.

—Christina Vogt

Reference:

TherapeuticsMD announces FDA approval of TX-004HR: IMVEXXY (estradiol vaginal inserts), the lowest dose vaginal estrogen product approved for the treatment of moderate to severe dyspareunia, a symptom of VVA, due to menopause [press release]. Boca Raton, FL. TherapeuticsMD. May 30, 2018. https://ir.therapeuticsmd.com/news-releases/news-release-details/therapeuticsmd-announces-fda-approval-tx-004hr-imvexxy-estradiol Accessed on May 30, 2018.