TherapeuticsMD (NSDQ:TXMD) said today that it won FDA approval for its applicator-free estradiol vaginal capsule, TX-004HR.
The soft-gel capsule is designed to treat moderate-to-severe vaginal pain experienced during sex, a symptom of vulvar and vaginal atrophy in women who have undergone menopause.
The Boca Raton, Fla.-based company plans to market the product under the name ‘Imvexxy’. This isn’t the first time that TherapeuticsMD tried to bring its drug to market – it’s first application to the FDA was rejected in May last year.
It’s not clear why the FDA changed its mind on this particular product, as it does not publish the letters that it sends to companies when it rejects a drug.
“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,” Dr. Brian Bernick, chief clinical officer, said in prepared remarks. “Imvexxy is the only product specifically designed to be applicator-free. It dissolves completely without mess or additional clean-up, and can be used anytime of day. It allows women the freedom to immediately return to their normal daily activities.”
“We are excited to bring Imvexxy to market as TherapeuticsMD’s first FDA-approved drug as we strive to be the premier women’s health company,” CEO Robert Finizio added. “Imvexxy will be offered at a price in parity with other products that have been on the market for 10 to 30 years. By ensuring patients can access Imvexxy at an affordable price, TherapeuticsMD is doing the right thing for women.”
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