Florida-based TherapeuticsMD is feeling a bit vindicated this morning after the U.S. Food and Drug Administration approved its vaginal pain medication.
Florida-based TherapeuticsMD is feeling a bit vindicated this morning after the U.S.Food and Drug Administration (FDA) approved its vaginal pain medication one year after the regulatory agency rejected the medication over safety concerns.
In its May 2017 Complete Response Letter to TherapeuticsMD the FDA raised concern over the lack of long-term endometrial safety data for TX-004HR beyond the 12-weeks studied in the pivotal Phase III trial. In November 2017 the FDA reversed course on its spring rejection of Imvexxy, formerly known as TX-004HR, and allowed the company to resubmit its New Drug Application. The company did so and the agency finally approved the medication for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Imvexxy (estradiol vaginal inserts), is the only product in its therapeutic class to offer a 4 mcg and 10 mcg dose, the company said. The 4 mcg represents the lowest approved dose of vaginal estradiol available, TherapeuticsMD added.
Vulvar Vaginal Atrophy affects an estimated 32 million postmenopausal women in the US. Only about seven percent (2.3 million) of these women receive prescription treatment, the company said. About 50 percent of women will experience pain during intercourse due to VVA at some point during their lives, TherapeuticsMD said.
TherapeuticsMD was one of three companies in 2017 that the FDA changed course on a drug it had previously rejected. In July the regulatory agency first reversed course on Amicus Therapeutics’ Fabry disease treatment. The FDA also reversed its decision on Eli Lilly’s rheumatoid arthritis drug baricitinib.
Brian Bernick, chief medical officer of TherapeuticsMD, said that Imvexxy provided a fraction of the estrogen contained within the average doses of other products on the market for the condition.
“Imvexxy is the only product specifically designed to be applicator-free. 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. Studies showed, that in patients who used Imvexxy systemic absorption of estradiol remained within postmenopausal range,” Bernick said in a statement.
The approval of Imvexxy marks the first FDA-approved therapy for TherapeuticsMD. The company hopes the approval will spur additional successes as it seeks to become the premier women’s health company, Chief Executive Officer Robert Finizio said.
When Imvexxy hits the market the company said it will be sold 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,” Finizio said in a statement.
