Treatment for menopausal women OK’d

Boca Raton firm gets FDA approval for ‘painful sex’ remedy

BOCA RATON — A Boca Raton company has a new product for menopausal women who experience painful sex.

The Food and Drug Administration has approved TherapeuticsMD’s Imvexxy treatment, the company said in a regulatory filing on Wednesday.

TherapeuticsMD, which is focused on health products for women, said vaginal dryness and painful intercourse can occur when a woman’s body makes less estrogen due to menopause. The insert is a “vaginal estrogen product that offers a fraction of the estrogen contained in the average doses of many existing products currently on the market,” said Dr. Brian Bernick, chief clinical officer of TherapeuticsMD.

It is expected to be commercially available in July, the company said.

TherapeuticsMD CEO Robert Finizio said the new treatment will be offered at a price “in parity with other products that have been on the market for 10 to 30 years.”

The FDA’s approval of Imvexxy is based on the results of a Phase 3, doubleblind clinical trial that evaluated the safety and efficacy of 4 mcg and 10 mcg dosages, compared with a placebo for 12 weeks. The most common adverse reaction with the treatment was a headache, an incidence of 3 percent or less, according to TherapeuticsMD.

Despite the FDA approval, the company faces some big-name competition in the pharmaceutical industry. In the vaginal product category, competitors could include Allergan’s Estrace Cream, Pfizer’s Premarin Cream and Novo Nordisk’s Vagifem.

Imvexxy is one of two products that have been under development by TherapeuticsMD. The com-