The FINANCIAL — Abbott Park, Illinois — Abbott announced today that the U.S. Food and Drug Administration (FDA) has approved a new 45 mg for six-month administration formulation of Lupron Depot® (leuprolide acetate for depot suspension), a medication used for the palliative treatment of advanced prostate cancer.
"Lupron Depot is an important treatment option for many patients with advanced prostate cancer," said Eugene Sun, M.D., vice president, Global Pharmaceutical Development, Abbott. "Approval of a new six-month formulation means that physicians and patients who have chosen Lupron Depot now have an additional treatment option."
Patients with advanced prostate cancer who have been prescribed Lupron Depot receive an injection that is administered in the physician office. The three current formulations of Lupron Depot have allowed patients to receive their treatment every month, every three months or every four months. Now, patients who are prescribed the newly approved formulation may receive their treatments every six months, providing additional dosing flexibility for patients with advanced prostate cancer.
Lupron Depot works by suppressing the production of the hormone testosterone. This decrease in testosterone can help slow or stop the growth of hormone-dependent cancer cells, and may relieve pain and other symptoms related to advanced prostate cancer.
Abbott's submission to the FDA was supported by new data from a 48-week, open-label study involving 151 patients with prostate cancer. Patients received a total of two injections, 24 weeks apart, and were followed for nearly one year to evaluate testosterone suppression 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. The most common side effects from this 48-week study were flushing, injection site pain, respiratory infection and fatigue. The 45 mg for six-month administration formulation is expected to be available in late June.
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