Abbott announced today that 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
“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