Abbott's sNDA for new six-month 45-mg formulation of Lupron Depot: FDA accepts for review

The U.S. Food and Drug Administration (FDA) has accepted for review the supplemental new drug application (sNDA) of a new six-month 45-mg formulation of Lupron® Depot (leuprolide acetate for depot suspension) for use in the palliative treatment of advanced prostate cancer.  Palliative treatment helps to relieve symptoms associated with advanced prostate cancer.  Lupron Depot works by suppressing the production of the hormone testosterone.  This decrease in testosterone, which helps slow or stop the growth of hormone-dependent cancer cells, may relieve pain and other symptoms related to advanced prostate cancer.  

"For many patients with advanced prostate cancer, Lupron Depot is an important treatment option because it can help manage the symptoms of their disease," said Eugene Sun, M.D., vice president, Global Pharmaceutical Development, Abbott. "Abbott is seeking approval for a new six-month formulation to provide greater convenience and dosing flexibility to physicians and patients who could benefit from this medication."

Lupron Depot is currently available in one-month (7.5 mg), three-month (22.5 mg) and four-month (30 mg) depot formulations.  Abbott's submission is supported by new data from a 48-week study involving 300 patients with prostate cancer.  Patients received a total of two injections, 24 weeks apart, and were followed for nearly one year to evaluate efficacy and safety.  Overall, testosterone suppression with this new 45-mg six-month depot formulation was sustained in patients throughout the treatment period.  The onset of testosterone suppression was consistent with other currently available Lupron Depot formulations.

SOURCE Abbott