Breast Pain
BHR Pharma has formulated a topical gel of Afimoxifene (4-hydroxytamoxifen or 4-OHT), one of the most active metabolites of tamoxifen, using Enhanced Hydroalcoholic Gel Technology (EHG™). The gel is applied directly to the breast for transdermal delivery to the breast tissue. In previous clinical trials, Afimoxifene gel has been shown to be biologically active in the breast tissue, while having systemic exposure in the plasma that is nine times lower than that of oral tamoxifen.
It's not a medical condition that's talked about much, but cyclic breast pain affects millions of American women. As many as 11 million premenopausal women suffer from moderate-to-severe breast pain.
Understanding Breast Pain
Also known as cyclical 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.
Treating Breast Pain
There are currently no approved, safe, and well-tolerated treatments for cyclic breast pain. In a clinical trial of 117 healthy premenopausal women with moderate-to-severe cyclic breast pain, however, Afimoxifene topical gel was shown to be effective in significantly improving the signs and symptoms of cyclic breast pain. The study further found that Afimoxifene gel is generally well-tolerated; headaches were the most common side effect, which were mild and similar across treatment groups. Menstrual cycles and menses were not disrupted over the course of the treatment period and hormonal plasma levels did not change.
This Phase 2 study – placebo-controlled, double-blind, dose-ranging, and randomized – indicated that transdermal Afimoxifene gel may represent a new way to treat cyclic breast pain.
