Ophena™ (ospemifene) is an investigational selective estrogen receptor modulator (SERM) in development for the treatment of postmenopausal vaginal atrophy. QuatRx has completed three Phase III clinical studies of Ophena™.

Post-Menopausal Population

In North America, Europe and Japan, it is estimated that there are more than 145 million postmenopausal women, a number that is projected to increase as the median age of the population increases. Postmenopausal women suffer from a number of conditions as a result of a decline in estrogen levels. These conditions include decreased bone density, known as osteoporosis, hot flashes and vaginal atrophy.

Vaginal Atrophy

Up to 40% of postmenopausal women suffer from vaginal atrophy, a chronic condition characterized by vaginal dryness, burning, irritation, itching and vaginal discharge. Dryness and irritation accompanying decreases in vaginal secretions and lubrication can often cause pain and/or bleeding during sexual intercourse. Associated urinary symptoms can include urinary frequency, pain on urination, urinary tract infections and incontinence. In contrast to hot flashes, which eventually disappear, vaginal atrophy persists as women age.

Vaginal atrophy results from a decline in estrogen levels that causes thinning of the vaginal cell lining. This condition leads to fragile vaginal mucous membrane characterized by decreased elasticity, paleness and disappearance of the small folds found in the vaginal wall. Vaginal secretions and blood flow to the vagina decrease, resulting in decreased lubrication. The decline in estrogen levels also leads to an increase in vaginal pH, creating an environment more susceptible to infection.