FDA approves 6-month formulation of GnRH agonist

The FDA has approved a new 45-mg, 6-month administration formulation of the gonadotropin releasing hormone agonist leuprolide acetate for depot suspension (Lupron Depot), for the palliative treatment of advanced prostate cancer.

Abbott Laboratories’ 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 1 year to evaluate testosterone suppression and safety.

Overall, testosterone suppression with the new formulation was sustained in patients throughout the treatment period. The onset of testosterone suppression was consistent with other currently available formulations. The most common side effects were flushing, injection site pain, respiratory infection, and fatigue.