Gynecomastia
Gynecomastia is present in males of all ages. Newborns receiving estrogen from their mother might have temporary symptoms of the condition, while adolescents encountering hormonal changes through puberty might experience symptoms as well. Adult males typically develop gynecomastia as a side effect of a disease or medication: for example, lung cancer, cirrhosis of the liver or an overactive thyroid. Steroid use or medications used to treat ulcers and epilepsy can also cause a hormone imbalance that can lead to gynecomastia. This effect is frequently seen in patients with prostate cancer, who are treated with hormone therapy that blocks the body from making androgens (male hormones). While reducing the growth of cancerous prostate cells, the lack of testosterone can lead to gynecomastia, as well as pain in the breast tissue.
For adolescents and newborns, gynecomastia is usually a temporary condition. In males with lasting symptoms, however, surgery is the most frequent and most effective answer.
BHR Pharma has developed Afimoxifene gel, a topical formulation of Afimoxifene (4-hydroxytamoxifen or 4-OHT), one of the most active metabolites of tamoxifen. Afimoxifene is an estrogen inhibitor that cannot be delivered orally due to high first-pass liver metabolism.
BHR plans to evaluate the effects of this investigational transdermal drug for the treatment of gynecomastia and associated breast pain. Results of a Phase 2 clinical trial in women using the drug 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 generally mild and similar across treatment groups.