HERNDON, Va., Dec. 8 /PRNewswire/ -- ASCEND Therapeutics, a leading researcher and developer of pharmaceutical transdermal therapies for the treatment of chronic conditions, today announced that its investigational transdermal 4-OHT gel reduced cyclic breast pain among premenopausal women, based on preliminary results obtained from a Phase 2 clinical study.
Cyclic breast pain is a potentially debilitating chronic disorder that causes significant pain while impacting everyday activities such as athletics, sexual intimacy, and social or professional activities. Cyclic breast pain, or mastalgia, is defined clinically as significant breast pain lasting more than seven days per month in the two weeks leading up to menses. The symptoms can cause significant stress when they are mistaken for early indicators of breast cancer, and often drive patients to seek out a mammogram. While breast pain is rarely a symptom of early breast cancer, women experiencing the condition have more frequent mammograms, biopsies and needle aspirations, compounding the anxiety associated with the underlying pain and increasing healthcare costs.
Prevalence studies indicate that approximately 8-11 million premenopausal women suffer from clinically defined cyclic breast pain in the United States. There are no approved, safe, and well-tolerated treatments for this condition.
ASCEND's study, which evaluated 4-OHT gel's safety and efficacy in treating cyclic mastalgia, was conducted in the United States and Europe. The Phase 2 randomized, double-blind, dose-ranging, placebo-controlled trial included 130 premenopausal women who had at least a four-month history of symptomatic breast pain. Transdermal administration of a 4 mg dose of 4-OHT gel to the breast yielded a statistically significant decrease in an objective measure of cyclic breast pain from baseline. In addition, 4-OHT gel showed a statistically significant reduction in the patient's subjective assessment of pain, the physician's assessment of pain, and the physician's clinical assessment of mastalgia. Headaches were the most common side effect, which were in general mild and similar across treatment groups
"Cyclic breast pain is a large unmet medical need," said Jay Bua, president and CEO of ASCEND. "Because there is no current clear standard of care, the condition is often not discussed openly, and women are unaware that millions of others like them suffer significant pain and anxiety. We are optimistic about bringing to market a well-tolerated and effective treatment that will help the millions of women who currently suffer from this painful and debilitating breast condition."
As a result of the positive Phase 2 results, ASCEND plans to meet with the Food and Drug Administration in the coming months to discuss the design and implementation of Phase 3 trials.
About ASCEND Therapeutics
ASCEND Therapeutics is a biopharmaceutical company focused on the use of transdermal drug delivery technology to overcome therapeutic barriers and raise the standard of care for certain chronic conditions. For more information about ASCEND, you may visit the company's web site at http://www.ascendtherapeutics.com/