• TherapeuticsMD got a green light from the Food and Drug Administration for TX-004HR, a treatment for moderate-to-severe dyspareunia, or vaginal pain during sexual activity caused by vulvar and vaginal atrophy during menopause.
• To be marketed under the name Imvexxy, TherapeuticsMD plans to launch the estradiol vaginal softgel capsule in July at a price that CEO Robert Finizio called “in parity with other products that have been on the market for 10 to 30 years.”
• The approval was announced a day after the company’s user fee action date and comes after a previous rejection in early 2017. The label includes a boxed warning that accompanies most estrogen products, and TherapeuticsMD will have to conduct a post-approval observational study.

Investors were concerned that the previous rejection was the end of TX-004HR, when the FDA asked for long-term safety data. But after meeting with the agency, the company was able to garner the approval of both the 4 mcg and 10 mcg doses based on a 12-week Phase 3 study, as well as a substudy of the pharmacokinetics.

“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, chief clinical officer of TherapeuticsMD.

He also boasted that the drug is applicator-free, “dissolves completely without mess or additional clean-up, and can be used anytime of day.”

In preparation of the launch, the company hired 15 regional managers and intends to hire another 150 sales reps.

“Today’s approval triggers the availability of the first $75 million tranche of the recently placed $200 million term loan, which complements the already $105 million in cash on hand, and will be used to support the commercialization efforts,” wrote Cowen & Co. analyst Ken Cacciatore.

“Additionally, this funding will also support the non-branded vulvar and vagina atrophy (VVA) disorder awareness marketing campaign that is already well underway, and which will likely now be broadened. We believe management is well prepared to successfully introduce this differentiated asset,” he wrote.

Dyspareunia is a condition that many menopausal and post-menopausal women experience, and the company estimates that 32 million develop VVA. But as few as 7% receive treatment.

One concern is that hormone therapies can cause endometrial cancer, cardiovascular disorders, breast cancer and probable dementia. While Imvexxy carries this same warning since it contains estrogen, analysts and the company point out that — particularly with the lower dose — there is low-to-no systemic estrogen, making it potentially safer than these other hormone products.