FDA agrees Teverelix LA's US development path

Edinburgh, UK-based Ardana has reported a positive outcome from a pre-Investigational New Drug meeting with the US Food and Drug Administration for the development of its lead development compound, the gonadotrophin antagonist Teverelix Long-Acting for the treatment of endometriosis. According to the firm, the pre-IND meeting resulted in agreement with the FDA on the clinical development path for Teverelix LA in this indication. Ardana plans to open an IND in 2008 and submit the first Phase II study design shortly thereafter.

Endometriosis arises in pre-menopausal women when the lining of the womb grows outside the uterus, typically in the pelvic cavity. Symptoms associated with the condition include cyclical or chronic pelvic pain, heavy periods and infertility. It is well documented that endometriosis is a hormone-sensitive condition and a reduction in estrogen levels causes a shrinkage of the endometriotic lesions and an improvement in symptoms. Current treatment options include GnRH agonists, however, this class of compounds is associated with side effects similar to menopausal symptoms including hot flashes, reduced libido and loss of bone density due to the reduction in estrogen levels to those seen in post-menopausal women, Ardana noted.