Hot flashes? Boca Raton company’s pill is approved by feds

Boca Raton-based TherapeuticsMD on Monday announced its single-pill hormone therapy for menopausal hot flashes has been approved for marketing by the U.S. Food and Drug Administration.

The new drug, which combines estradiol (estrogen) and progesterone in an oral softgel capsule, has been named Bijuva, and is expected to be available in the United States by April or May, the company said.

For menopausal women, the approval means a new option for hormone therapy. Currently, women who want bio-identical hormone therapy — molecularly identical to the hormones produced by the body — have to take two pills.

For the company, it means further entrance into a multibillion-dollar market of menopausal health care for women.

“This marks another important milestone for the company,” Rob Finizio, CEO and co-founder of TherapeuticsMD, said during a conference call Monday with Wall Street analysts. The company now has three FDA-approved women’s health-care products to distribute.

Dr. James Liu, president of the North American Menopause Society and chairman of Obstetrics and Gynecology at University Hospitals Cleveland Medical Center, said this is the first FDA approval of a combination hormone therapy “evaluated in a large, wellcontrolled, randomized clinical trial that has demonstrated both safety and efficacy for the treatment of moderate to severe hot flashes due to menopause.

“The approval of Bijuva

represents an important, novel and effective treatment option for women,” Liu said.

And with FDA approval, the combination product “can be covered by insurance,” Finizio said.

TherapeuticsMD’s approval of Bijuva, as well as of an earlier product, opens up a huge market to the company. Menopause symptoms affect more than 30 million women in the United States alone, resulting in a market opportunity of $20 billion to $25 billion for the drug, according to a regulatory filing by the company.

In August, TherapeuticsMD began distributing Imvexxy, its new treatment for menopausal women who experience painful sex due to vaginal atrophy. Imvexxy was approved for marketing by the FDA in May. The company also acquired exclusive rights in September to market FDA-approved Annovera, a new birth control method for women.

TherapeuticsMD, a public company whose stock is traded on Nasdaq, has been developing women’s healthcare products for more than 10 years. The company’s stock closed Monday at $4.77 a share, down 32 cents or 6.29 percent.

Earlier this month, it was named Company of the Year by the state biotech organization BioFlorida.

CARLINE JEAN/SOUTH FLORIDA SUN SENTINEL Rob Finizio, left, and Dr. Brian Bernick are co-founders of TherapeuticsMD in Boca Raton.