FDA approval for TherapeuticsMD, one year after initial rejection
TherapeuticsMD has succeeded in changing the FDA’s mind on its Imvexxy product, after an initial rejection in May of last year turned into an approval second-time round.
Imvexxy is a treatment for moderate-to-severe dyspareunia, a symptom of vulvar and vaginal atrophy, as a result of menopause, that leads to pain during sex.
The FDA had originally turned the treatment away, after asking for a greater scope of safety data with a 12-month trial instead of the 12-week program TherapeuticsMD had initially offered.
In the end, the Agency relented and allowed the biotech to reapply, on the condition that it conducts a post-approval safety study.
There are already numerous such estrogen replacement therapies on the market; however, TherapeuticsMD claims that its USP is that it can be offered in the lowest dose on the market, at 4mcg of vaginal estradiol.
“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,” said Robert Finizio, Chief Executive Officer of TherapeuticsMD. “Imvexxy reflects our long-standing corporate mission and commitment to health solutions that women want, based on the concepts of medical need, efficacy, safety, simplicity, and affordability. 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.”
The company noted that the only observable side-effect in clinical trials differentiating the treatment from placebo was the greater incidence of headaches in those taking Imvexxy.
However, the product will still have to bear a label indicating the dangers of estrogen therapy, which include an increased risk of endometrial cancer, cardiovascular disorders, breast cancer, and probable dementia.
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