THERAPEUTIC AREAS

Breast Pain

Understanding Breast Pain

It's not a medical condition that's talked about much, but cyclic breast pain affects millions of American women. Published prevalence studies, including a study conducted by Dr. Deborah Ader of the National Institutes of Health indicate as many as 11 million premenopausal women suffer from moderate to severe breast pain.

Also known as cyclic mastalgia, cyclic breast pain is defined as significant breast pain in the two weeks leading up to menses, when it usually subsides. While some pain one to four days before the period is considered normal, many women experience severe pain that lasts more than seven days per month. About 10-15% of all women suffering with cyclic breast pain experience pain of such severity that ordinary activities like sleep, participation in athletics - even intimate relations - are disrupted.

Although the condition is not usually an early symptom of breast cancer, many patients with this condition undergo further screening to rule out the possibility of cancer. The nature of the condition often results in frequent unnecessary mammograms, needle aspirations and biopsies, as well as increased patient concern and anxiety.

Breast pain is related to fluctuating hormone levels. There is no effective standard of care without significant side effects for the treatment of cyclic breast pain. ASCEND Therapeutics is investigating a transdermal therapy called afimoxifene gel (4-hydroxytamoxifen). Results of a Phase 2 clinical trial of afimoxifene gel indicate that the treatment was well tolerated and showed a statistically significant reduction in cyclic breast pain. In this trial, headaches were the most common side effect, which were in general mild and similar across treatment groups.